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Articles in category: Legal, Clinical & Regulatory

Are Virtual Product Development Brainstorming Sessions Leading to Patent Inventorship Issues?

by John W. Boger, Esq. | Apr 2021

Incorrect inventors could lead to patents being deemed invalid. Companies should follow best practices like creating a claim chart to avoid filing mistakes.   ...

Read more »

FDA Strengthens its Biocompatibility Focus with new Resource Center

by Patrick McGuire | Mar 2021

Biocompatibility is a topic of growing interest for FDA. The goal of the resource center is to explain terms and concepts important for the evaluation of biocompatibility of medical devices.   ... Read more »

Silver-Coated Bone Screw System Receives CE Mark for Expanded Indications

by Patrick McGuire | Mar 2021

Silver Bullet Therapeutics bone screws are designed to kill bacteria in 24 hours after surgery. The company’s new CE Mark contains no anatomical, clinical or design limitations, allowing their system to be used for all orthopedic indications.... Read more »

Additive Manufactured Talus Spacer Receives Humanitarian Use Designation from FDA

by Annie Zaleski | Mar 2021

Additive Orthopaedics’ Patient Specific Talus Spacer is meant to alleviate the impact of avascular necrosis.   ... Read more »

FDA 510(k) Recap: First Clearances for Companies in 1Q21

by Julie A. Vetalice | Feb 2021

New year, new entrants to the U.S. orthopedic market. This installation of the 510(k) recap offers up companies based in the U.S., China and Switzerland, and spans four of the major industry segments: Joint Replacement, Spine, Trauma and Sports Medicine.   ... Read more »

DePuy Synthes Gains FDA Clearance for VELYS Robot with ATTUNE Knee

by Julie A. Vetalice | Jan 2021

The VELYS Robotic-Assisted Solution adapts to the surgical workflow, and helps surgeons execute accurate bony cuts.   ... Read more »

EU Allows Notified Bodies to Conduct Audits Remotely

by Patrick McGuire | Jan 2021

While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could ease the backlog created by MDR and COVID.   ... Read more »

FDA 510(k) Recap: First Orthopedic Clearances

by Julie A. Vetalice | Jan 2021

This month’s recap informs you of companies entering the major orthopedic market segments with their first product clearance. The six companies we chose to highlight received their clearance within the last quarter of 2020. Geographically, they span the U.S., Australia and Italy.   ... Read more »


FDA Releases AI Action Plan for Medical Devices

by Patrick McGuire | Jan 2021

FDA’s five-point plan outlines the Agency’s thoughts on a tailored regulatory framework, good machine learning practices, patient approaches, technology biases and real world performance.   ... Read more »

Additive, AI, Digital Health Noted in FDA’s 2021 Science Report

by Carolyn LaWell | Jan 2021

FDA published its Focus Areas of Regulatory Science report, prioritizing research across the strategic initiatives of data, increasing choice and competition through innovation and empowering patients.   ... Read more »

FDA Adds Bone Screws and Spine Plates to Alternative 510(k) Pathway

by Carolyn LaWell | Jan 2021

The voluntary Safety and Performance Based Pathway allows manufacturers with moderate-risk devices to meet specific performance criteria instead of testing against a predicate device to demonstrate equivalence.   ... Read more »

FDA 510(k) Recap: 2020 Highlights Across the Market Segments

by Julie A. Vetalice | Dec 2020

Close to 550 orthopedic products received clearances in this hectic year, allowing us to keep this popular monthly 510(k) recap relevant. Here are 10 clearances that I found to be of interest throughout 2020.   ... Read more »

Clinical Trials Shift to Hybrid Approaches in the Age of COVID-19 and Beyond

by Heather Tunstall | Nov 2020

Conducting successful clinical trials will require orthopedic companies to demonstrate flexibility and adaptability in the future.... Read more »

First 510(k)s for Companies in Joint Replacement, Spine, Trauma, SportsMed and Obio

by Julie A. Vetalice | Nov 2020

This month’s recap rounds up many companies new on our radar, helmed by people who've known the industry for a long time. Geographically, they span the U.S., Canada, France and Turkey.   ... Read more »

How to Take a Risk-Based Approach to Biocompatibility

by Patrick McGuire | Nov 2020

The ISO 10993-1 changes have re-emphasized the need for orthopedic companies to understand and characterize the materials, processes and risks associated with medical devices.... Read more »

MDR Experts Share How to Successfully Navigate the Requirements

by Sharon Starowicz | Oct 2020

Notified Body representatives and regulatory consultants provided an update on MDR compliance at OSMA's summer meeting. We review the advice around significant change, legacy devices, economic suppliers and more.... Read more »

FDA 510(k) Recap: Companies Gain Trauma Device Clearances

by Julie A. Vetalice | Oct 2020

As the Orthopedic Trauma Association holds its Annual Meeting this week, we look at companies that seek to make a clinical difference in trauma surgery.... Read more »

FDA 510(k) Recap: First Clearances in 2020

by Julie A. Vetalice | Sep 2020

We profile five companies that received their first FDA 510(k) clearances in 2020. Three of these companies are headquartered outside of the U.S. and these clearances mark their entry into the market. ... Read more »

10 Spine Companies Receive Their First FDA 510(k)

by Julie A. Vetalice | Sep 2020

Thus far in 2020, ten companies received their FDA 510(k) clearances that were not only firsts for the company, but also obtained for a spine product.... Read more »

FDA 510(k) Recap: Total Ankle Clearances in 2020

by Julie A. Vetalice | Aug 2020

The total ankle market is attractive for current and new players. We review four total ankle devices, three from new entrants in the space, that received FDA 510(k) clearance this year.... Read more »

FDA Update: Inspections Return, De Novo Classification and ISO 13485 Added to Agenda

by Julie A. Vetalice | Jul 2020

 FDA has made multiple announcements in recent weeks, including the return of domestic inspections as well as decisions on De Novo Classification and harmonization with ISO 13485.... Read more »

FDA 510(k) Recap: Spine Company Clearances

by Julie A. Vetalice | Jul 2020

Spine continues to commercialize more products than other orthopedic sectors due to players of all sizes launching a robust list of new products each year. This month, we recap multiple launches from CarboFix Orthopedics, Cutting Edge Spine, Life Spine, Medacta and SeaSpine.... Read more »

Engage Surgical Gains FDA Clearance for Cementless Partial Knee

by Julie A. Vetalice | Jul 2020

This is reported to be the only cementless partial knee system available in the U.S. It is cleared for both cementless or cemented fixation.   ... Read more »

IlluminOss Gains FDA Clearance for Treatment of Pelvic, Clavicle and Small-Bone Fractures

by Julie A. Vetalice | Jul 2020

The new indication expansion significantly broadens opportunities to address the geriatric fragility fracture market.   ... Read more »

FDA Repeats Call for Advanced Manufacturing Efforts

by Carolyn LaWell | Jul 2020

FDA's CDRH Director Dr. Jeffrey E. Shuren emphasized the need for a greater focus on Advanced Manufacturing during the MDIC 2020 Annual Public Forum. FDA leadership noted COVID-19 has furthered its Advanced Manufacturing efforts, which will be tied to the Case for Quality Initiative. ... Read more »

FDA 510(k) Recap: Lesser-Known Companies and First Orthopedic Clearances

by Julie A. Vetalice | Jun 2020

FDA cleared 40 orthopedic products in May. We highlight four companies that may be new names to you as well as their technology. ... Read more »

How to Incorporate Software Validation in Your Device Design and Quality Processes

by BONEZONE | May 2020

In our latest Ask the Expert article, we answer how software validation fits with your SOPs for design validation and process validation. ... Read more »

FDA 510(k) Recap: Line Extensions and Small Companies

by Julie A. Vetalice | May 2020

FDA's orthopedic panel cleared 49 products in April, we’ve chosen updates from Arthrex, Medacta, OrthAlign, Akros Medical and Subchondral Solutions.... Read more »

How Will FDA's CDRH Reorganization Impact Me?

by BONEZONE | May 2020

The goal of the CDRH reorganization was to drive operational efficiencies. Some organizations will feel the impacts of changes more quickly than others.... Read more »

FDA 510(k) Recap: Joint Replacement Updates and Line Extensions

by Julie A. Vetalice | Apr 2020

To date in 2020, joint replacement players like Arthrex, Conformis, DePuy Synthes, Medacta, Zimmer Biomet and others have gained FDA 510(k) clearance for a variety of updates and line extensions for their knee, hip and shoulder devices.    ... Read more »

EU MDR Postponement Clears Another Hurdle

by Carolyn LaWell | Apr 2020

The European Parliament voted to postpone MDR until 2021. The regulation's postponement now moves to its final steps. ... Read more »

OrthoSensor Gains 510(k) Alignment Clearance for VERASENSE for use with Zimmer Biomet's Persona Knee

by Julie A. Vetalice | Apr 2020

VERASENSE is a sensor-assisted device used with leading knee implant systems during primary and revision total knee procedures.   ... Read more »

FDA Approves Centinel Spine’s Two-Level prodisc L for Total Disc Replacement

by Julie A. Vetalice | Apr 2020

prodisc L is the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine.   ... Read more »

Extremity Medical Gains FDA Clearance for KinematX Total Wrist

by Julie A. Vetalice | Mar 2020

The device is specifically designed to negate common risks of radial implants, such as limited range of motion, subluxation, distal component failure and osteolysis.   ... Read more »

COVID-19: What CDRH Wants You to Know about Regulatory Submissions and Clinical Trials

by Julie A. Vetalice | Mar 2020

FDA’s Center for Devices and Radiological Health issued a letter to industry regarding what to expect as companies and the agency respond to the COVID-19 pandemic. In general: expect help.   ... Read more »

DePuy Synthes Announces CE Mark for BI-MENTUM Dual Mobility Hip

by Julie A. Vetalice | Mar 2020

Currently available in the U.S., BI-MENTUM is slated to enter European markets in April 2020. The system complements other hip stems with highly polished necks, including the company's CORAIL Hip System that has more than 2.5 million implantations to date.  ... Read more »

MDR Deadline Still On—for Now

by Carolyn LaWell | Mar 2020

The European Commission will propose delaying the MDR deadline by one year. The announcement came after MedTech Europe and others called on the commission to pause the regulation, noting that device companies’ response to COVID-19 disrupts their ability to meet the transition timeline date.  ... Read more »

How to Approach Risk Management Under ISO and MDR Updates

by BONEZONE | Mar 2020

Question: How do I handle medical device risk management and the change from ALARP to AFAP? Virginia Anastassova of StarFish Medical advises that staying current with the latest regulations, standards and guidance is key.   ... Read more »

FDA-Cleared Navigation, Planning and Robotic Systems

by Julie A. Vetalice | Feb 2020

Enabling technology will be a large focus in 2020. In preparation for announcements to come, we took stock of FDA 510(k) cleared products from 2018 to 2019.... Read more »

Arthroscopy Pumps Targeted in New FDA Guidance

by Carolyn LaWell | Feb 2020

FDA released draft guidance for 510(k) submissions of arthroscopy pump tubing sets intended for multiple use after receiving reports of backflow of patient fluids.... Read more »

In2Bones Gains FDA Clearance for Quantum Total Ankle

by Julie A. Vetalice | Feb 2020

The clearance marks the company’s entrance into the total ankle replacement market and complements its products for upper and lower extremities.    ... Read more »

FDA 510(k) Recap: 9 First Clearances and Line Extensions

by Julie A. Vetalice | Jan 2020

This month’s recap highlights devices of interest that received first clearances from companies new on our radar, like Augmedics, Avanti Orthopaedics, NanoOrtho, Nebula Surgical and Sonex Health, and the latest devices from Integra, Think Surgical, ExsoMed and Pantheon Spinal.... Read more »

ISO 14971 Update Recognized by FDA, Aligned with EU MDR on Risk Management

by Heather Tunstall | Jan 2020

The medical device risk management standard was updated to better align with changes in medical device regulations around the world. The standard emphasizes postmarket surveillance, is recognized by FDA and aligns with EU MDR requirements. ... Read more »

Silver Bullet Therapeutics Gains CE Mark for OrthoFuzIon Bone Screw

by Julie A. Vetalice | Jan 2020

An expanded CE Mark positions the company to improve patient care in the EU, and potentially disrupt the established commercial trauma market.   ... Read more »

Augmedics Launches xvision AR Surgical Guidance

by Julie A. Vetalice | Jan 2020

The augmented reality system allows surgeons to visualize anatomy in real time, as if using x-ray vision, to guide instruments and implants. The first application addresses spinal procedures.   ... Read more »

Empirical Spine Completes Portion of Enrollment for LimiFlex Clinical Trial

by Julie A. Vetalice | Dec 2019

Enrollment is complete in the investigational arm of the U.S. IDE trial of the LimiFlex Paraspinous Tension Band with decompression.   ... Read more »

Lack of Clinical Evidence Leaves Questions about Orthobiologic Development and Promotion

In the race to capitalize on patient-driven interest in stem cells, biologic and regenerative solutions, there has been an explosion of offerings that lack scientific controls, validity and meaningful evidence. Companies now have until November 2020 to comply with new FDA regulations. Enforcement, t... Read more »

CMS to Remove Total Hip Replacement, Certain Spine Procedures from Inpatient Only List

by Julie A. Vetalice | Dec 2019

Removal of these procedures from the inpatient-only list makes them eligible to be paid by Medicare in hospital outpatient and inpatient settings.   ... Read more »

3 FDA Actions to Reduce Ethylene Oxide Sterilization

by Heather Tunstall | Dec 2019

FDA has prioritized the reduction of ethylene oxide to sterilize medical devices. Recent announcements from the agency provide orthopedic manufacturers insight into how and why they should consider adopting new sterilization processes.... Read more »

FDA 510(k) Review: 2019 Additively-Manufactured Product Clearances

by Julie A. Vetalice | Dec 2019

Spine implants accounted for the majority of the additive manufactured products that received FDA 510(k) clearance in 2019. Our review of clearances include the industry's top players and two companies with their very first orthopedic-related 510(k)s: Additive Implants and Addivation Medical.... Read more »

FDA 510(k) Recap: 10 Products in Joint Replacement and Spine

by Julie A. Vetalice | Nov 2019

This month, we look at companies that received their first orthopedic-related clearance such as FX Shoulder USA, Amplify Surgical and restor3d, and others like Exactech, Smith+Nephew and THINK Surgical that have interesting new technologies or line expansions.... Read more »

New Trademark Laws Stress Quality and Integrity of Registration

by John W. Boger, Esq. | Nov 2019

The United States Patent and Trademark Office has enacted policy changes to post-use audits and foreign applications. The new laws focus on the quality of trademarks and are a reminder for device companies to implement best practices to retain their trademark.  ... Read more »

CMS Increases Medicare Physician Payment for Minimally Invasive SI Joint Fusion

by Julie A. Vetalice | Nov 2019

Companies affected by this change include RTI Surgical, marketer of the SImmetry® system, and SI-BONE, manufacturer of the iFuse Implant System®.   ... Read more »

DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial

by Julie A. Vetalice | Nov 2019

The first of its kind biomaterial is offered as an alternative to PEEK and titanium materials for interbody devices.   ... Read more »

FDA 510(k) Success Dependent upon Pre-submission Planning

by Heather Tunstall | Nov 2019

How should you prepare for FDA 510(k) submissions in 2020? Start with a thorough understanding of the testing and verification and validation work you need to complete prior to submission.... Read more »

FDA Applies Special Controls to Instrumentation for Certain Osteochondral Implants

by Julie A. Vetalice | Nov 2019

FDA has ruled to classify orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls).... Read more »

Stryker Gains FDA Clearance for SAHARA Lateral 3D Expandable Interbody

by BONEZONE | Oct 2019

Stryker received FDA 510(k) clearance to market the SAHARA® Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology. This is the first and only 3D-printed lateral expandable device on the market.   ... Read more »

FDA Announces Advisory Panel, Releases Report on Metal Implants

by Heather Tunstall | Oct 2019

FDA says gaps exist in both knowledge and the available tools that are necessary to understand and assess biological responses to metal implants in clinical and regulatory contexts. In acknowledging these challenges, FDA scheduled an Immunology Devices Panel Advisory Committee meeting and published ... Read more »

FDA 510(k) Recap: 10 Shoulder Implants and Technologies

by Julie A. Vetalice | Oct 2019

Nine shoulder replacement implants, including two stemless offerings, and one positioning guide received FDA 510(k) clearance thus far in 2019. We recap each product's specifications.   ... Read more »

Process Validation Requires that You First Determine Scope

by Kim Snell | Sep 2019

What is the current industry thinking on process validation? Our Ask the Experts series posed to the question to Carolyn Guthrie, Director of Regulatory Affairs and Quality Assurance, Kapstone Medical.... Read more »

Active Implants Gains FDA Breakthrough Device Designation for NUsurface Meniscus

by Julie A. Vetalice | Sep 2019

Breakthrough Device Designation is designed to ensure that patients and providers have timely access to vital devices. If cleared by FDA, NUsurface would be the first artificial meniscus in the U.S. market.   ... Read more »

Complaints and Clinical Evaluations: What Reporting Actions Should You Take?

by Kim Snell | Sep 2019

Regulatory and quality orthopedic professionals offer advice on ways that they would manage the gray areas of complaint reporting and clinical evaluation writing.... Read more »

Zimmer Biomet Gains FDA Approval for Tether Scoliosis Treatment

by Julie A. Vetalice | Aug 2019

The Tether represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years.   ... Read more »

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

by Julie A. Vetalice | Aug 2019

Heading into the NASS Annual Meeting, we share product clearances for lesser-known companies to keep on your radar: Integrity Implants, MiRus, Omnia, Silony and more. ... Read more »

CMS Proposes Total Knee and Total Hip Outpatient Changes

by Julie A. Vetalice | Aug 2019

The Center for Medicare and Medicaid Services announced its recommendation to cover total knee replacement in ASCs and total hip replacements in outpatient settings.... Read more »

A Solid Quality System Will Help You Adapt to Changing Regulations

by Kim Snell | Jul 2019

Incorporate sound quality management systems into the production of new products and processes so that regulations become guiding principles for continued growth as opposed to hurdles that companies fear.... Read more »

FDA 510(k) Recap: Large Players Notch Sports Medicine and Orthobiologics Clearances

by Julie A. Vetalice | Jul 2019

Arthrex, CONMED, DePuy Synthes and Zimmer Biomet are among the companies that received FDA 510(k) clearances in June.... Read more »

FDA Challenges Industry to Find Sterilization Alternatives after Sterigenics, Viant Announce Facility Closures

by Julie A. Vetalice | Jul 2019

FDA's study of new sterilization methods is in response to ethylene oxide sterilization facility closures. The closures were promoted by air quality issues and created a shortage of sterilization options for some medical device companies.... Read more »

Benvenue Medical Gains FDA Clearance for Luna XD MIS Expandable Interbody

by Julie A. Vetalice | Jul 2019

The next-generation system was designed to improve simplicity and ease of use for minimally invasive lumbar procedures, and is part of a lumbar fusion solution suite that also includes Orbit discectomy instruments.   ... Read more »

DT MedTech Granted PMA for Hintermann H3 Total Ankle

by Julie A. Vetalice | Jun 2019

The H3 was developed by Prof. Dr. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The H3 has been implanted in more than 20,000 patients outside of the U.S. since its first release in May 2000.   ... Read more »

FDA 510(k) Recap: Knees, Hips, Shoulders, Wrists and Elbow Joints

by Julie A. Vetalice | Jun 2019

This month we focus on products that rebuild knees, hips and extremities. Two are from companies receiving their first orthopedic-related clearance; most are from folks that you know: LimaCorporate, MicroPort Orthopedics, Zimmer Biomet, and so forth.   ... Read more »

AMDT Gains FDA Clearance for SixFix Hexapod Device

by Julie A. Vetalice | May 2019

The external fixator device is designed to shorten surgical time, simplify inventory and enhance patient care, and is used with SixFix deformity analysis and correction software.  ... Read more »

THINK Surgical Completes Enrollment for Study of Active Robot for TKR

by Julie A. Vetalice | May 2019

The company has filed a submission to FDA for clearance to market its active robot for use in total knee replacement procedures.   ... Read more »

FDA's Pre-Submission Process Allows You to Minimize Risk and Decrease Cost

by BONEZONE | May 2019

Utilizing FDA's Pre-Submission Process provides an opportunity to address potential concerns early in the regulatory process, and it can significantly reduce the risk of delays once a 510(k) is under review.... Read more »

ChoiceSpine Granted FDA Clearance for New Cervical Spinal Fusion Devices

by Julie A. Vetalice | May 2019

With these 510(k)s in hand, TIGER SHARK C Cervical Interbody and BOOMERANG Anterior Cervical Plate are set to enter the robust spinal implant market.   ... Read more »

FDA 510(k) Recap: Shoulders and Ankles

by Julie A. Vetalice | May 2019

Shoulders and ankles comprise the largest share of the extremities joint reconstruction segment. Arthrex, Catalyst OrthoScience, DJO, Exactech, Stryker and Zimmer Biomet have continued to grow their offerings of these devices in 2019 to keep extremities replacement momentum going.    ... Read more »

UDI Convenience Kit Guidance Released by FDA

by BONEZONE | May 2019

FDA finalized UDI guidance for convenience kits and provided orthopedic-specific examples as context in the document.... Read more »

FDA Finalizes Guidance for UHMWPE used in Orthopedic Devices

by BONEZONE | May 2019

FDA released guidance regarding the characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices, providing manufacturers direction in determining the appropriate testing needed for regulatory submissions.... Read more »

Artoss Gains FDA Clearance of NanoBone SBX Putty for Standalone Use in Fusion

by Julie A. Vetalice | May 2019

NanoBone Bone Graft used as a standalone in posterolateral spinal fusion may represent a significant advancement in patient care. Eliminating the need to mix synthetic graft with autograft or to harvest and concentrate bone marrow aspirate can offer savings of time and money, and can ... Read more »

Konica Minolta Healthcare Gains FDA Clearance for Dynamic Digital Radiography

by Julie A. Vetalice | May 2019

Today, orthopedists rely on external motion and static x-ray to assess joint stability and spinal movement. With DDR, orthopedists and musculoskeletal specialists can acquire a full view of the skeletal system in supine and prone positions to view changes in the bone and articulations throughout the... Read more »

FDA Targets Device Materials, Releases Metal-on-Metal Study Results

by BONEZONE | Apr 2019

FDA is looking at materials used in medical devices, citing growing evidence that a small number of patients may have adverse biological responses to certain types of materials. As the agency rolls out new guidance, orthopedic manufacturers should expect greater scrutiny of materials during pre... Read more »

EU MDR: How to Respond to Today’s Knowns and Unknowns

by Carolyn LaWell | Apr 2019

Orthopedic device companies implementing EU MDR should consider these eight actions, while thinking strategically about the unknowns of the regulation.   ... Read more »

Brainlab Recalls Spine & Trauma 3D Navigation Software

by BONEZONE | Apr 2019

The recalled software is used with Brainlab's navigation system during spinal and trauma procedures, providing patient images to navigate surgical tools and implants used before and during minimally invasive procedures. FDA has identified this as a Class I recall.   ... Read more »

FDA 510(k) Recap: Adjacent Markets, Additive, Surgical Platforms

by Julie A. Vetalice | Apr 2019

Orthopedic companies large, mid-sized and small are gaining FDA clearance for products in new materials, and made with attractive manufacturing methods like 3D printing. Companies like Kuros Biomedical and Nvision are making strategic decisions to move into adjacent markets. ... Read more »

FDA Proposes Framework for Artificial Intelligence-Based Devices

by BONEZONE | Apr 2019

Artificial intelligence technology is evolving quickly, and the potential benefits of adaptive AI systems in relation to modern medicine are seemingly endless. FDA plans to establish a new regulatory framework for medical devices that use advanced AI algorithms.   ... Read more »

FDA Clears First Implant with Molybdenum Rhenium Superalloy

by Carolyn LaWell | Apr 2019

MiRus received FDA 510(k) clearance for Europa, a pedicle screw made with MoRe®, a proprietary molybdenum rhenium superalloy expected to provide more strength, ductility and durability than titanium and cobalt.   ... Read more »

Zimmer Biomet Gains FDA Clearance of ROSA ONE Spine System

by Julie A. Vetalice | Apr 2019

The company now has FDA 510(k) clearance for knee, spine and brain applications on one robotic platform. ROSA SPINE features dynamic tracking that allows it to move with the patient, supporting accuracy without the need to be attached to the patient or the surgical table.   ... Read more »

AAOS Recap: Regulatory Announcements from the Hall

by Julie A. Vetalice | Mar 2019

This month’s recap highlights regulatory announcements made from the AAOS exhibit hall floor. A few products gained clearance earlier this year and the company strategically held its announcement for this month.   ... Read more »

Atreon Orthopedics Receives FDA Clearance for Rotator Cuff Regeneration Device

by Julie A. Vetalice | Mar 2019

The Rotium Bioresorbable Wick supports the regeneration of healthy tendon in the healing of rotator cuff injuries.... Read more »

Exactech Gains FDA Clearance for Alteon Cup and XLE Liner

by Julie A. Vetalice | Mar 2019

The Alteon Cup is used with the Alteon XLE highly crosslinked vitamin-E enhanced acetabular liners. A patented gamma irradiation and mechanical annealing process, tailored to the vitamin E content, is used to achieve the desired crosslink density for these liners.... Read more »

CurvaFix Receives FDA 510(k) Clearance for CurvaFix Rodscrew

by Julie A. Vetalice | Mar 2019

CurvaFix is developing implantable products to improve bone repair following serious fracture and injury. This is the company’s first product, and first FDA 510(k) clearance.     ... Read more »

Device Companies Emphasize Coatings in FDA 510(k) Announcements

by Julie A. Vetalice | Mar 2019

Orthopedic joint replacement and spine companies tout their coatings as essential elements to new products.... Read more »

FDA 510(k) Recap: AQrate, ROSA and First Clearances

by Julie A. Vetalice | Feb 2019

In January, Globus Medical and Zimmer Biomet received key robotic FDA 510(k) clearances, while five companies within the spine, sports medicine and trauma markets received their first clearances.       ... Read more »

SIG Medical Gains Additional FDA Clearance for AdvantageRib System

by Julie A. Vetalice | Feb 2019

SIG seeks to provide patient care by reducing complications like pneumonia, time in intensive care units, chronic pain, ventilator support, chest wall deformity, the need for tracheostomy and a significant reduction to the overall cost to the healthcare system.... Read more »

Orthofix M6-C Disc Granted FDA Premarket Approval

by Julie A. Vetalice | Feb 2019

Clinical data on the disc demonstrated meaningful improvement in pain and lowered disability vs. anterior cervical discectomy and fusion in the treatment of cervical radiculopathy, with or without cord compression.... Read more »

Orthopaedic Companies Collaborate with NESTcc on Real-World Evidence Considerations

by Carolyn LaWell | Jan 2019

The National Evaluation System for health Technology Coordinating Center launched its first round of Real-World Evidence Test-Cases, which include a focus on postmarket surveillance in orthopaedics. NESTcc's Deputy Director discusses what manufacturers should know about Real-World Data and Real-Worl... Read more »

FDA 510(k) Recap: Companies Gaining First Clearances in 2018 and 2019

by Julie A. Vetalice | Jan 2019

Products highlighted here — representing the spine, joint reconstruction, trauma and arthroscopy/soft tissue segments — include a total hip, cervical plate, interbody fusion system, lumbar fusion system, spacer, pedicle screw systems and more. ... Read more »

FDA Works to Modernize 510(k) Process, Takes Aim at Predicates, De Novo Pathways

by John Gagliardi | Jan 2019

This more modern 510(k) pathway is to be used for clearance of low- to moderate-risk devices. It has a focus on predicate devices that are 10 years old or less, and its framework is aimed at efficiently advancing beneficial technology to patients while keeping with FDA’s standards for safety and e... Read more »

FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

by John Gagliardi | Dec 2018

By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well."... Read more »

Can You Trust E-Signatures From Your Software Package Vendor?

by Martin Browning | Dec 2018

Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is not validation. At a minimum, you must establish (note the regulatory meaning of that word) the validity of the e-signatures you want to accept based on you... Read more »

FDA Takes Several Steps to Strengthen Medical Device Cybersecurity Program

by BONEZONE | Dec 2018

In order to stay current with the evolving technological landscape and increased insight into cyber threats, FDA recently addressed cybersecurity, including updating previous guidance, a new cybersecurity playbook and a program with the Department of Homeland Security.... Read more »

FDA 510(k) Highlights from 2018: Shoulder and Ankle Joint Replacement Products on Tap

by Julie A. Vetalice | Nov 2018

Several of these clearances reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated designs, allowing companies to offer a wider array of products. ... Read more »

Crucial Validation Considerations for Instrument Cases and Trays

by Rob Meyer | Oct 2018

Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. ... Read more »

How to Respond to FDA Inspection Observations, Even Those You Dispute

by Martin Browning | Oct 2018

Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are in control of the situation and are attempting to comply voluntarily by doing everything possible and reasonable to ensure that your products meet Agency specifications."... Read more »

b-ONE Ortho Gains FDA 510(k) Clearance for Total Hip

The b-ONE™ cementless total hip system is the company’s first product following a US $20.0MM round of Series A financing.... Read more »

25 Considerations for Companies Seeking Clarity in Design Controls

by John Gagliardi | Sep 2018

OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices are often the result of informal development that does not ensure proper establishment and assessment of these requirements. ... Read more »

510(k) Recap: New Products from Companies You Know

by Julie A. Vetalice | Aug 2018

We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and more are supporting new product launches and maintaining their growth.... Read more »

How the European Union's MDR Will Impact Your Company's Supply Chain

by Carolyn LaWell | Aug 2018

OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to meet regulatory requirements, timelines for CE Mark approval and make critical considerations for audits.... Read more »

FDA Responds to Additive Questions on 510(k) Submissions, Reusing Powder, Testing

by Carolyn LaWell | Aug 2018

An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the insight provided: "Have a good process flow map of all of the steps involved. People tend to focus on the printing portion, but there are a number of steps upstream and... Read more »

12 Growing Orthopaedic Companies Expand Their Patent Portfolios

by BONEZONE | Jul 2018

A review of patent activity in 1H18 shows technological innovations from companies like Episurf, iOrthopedics, Orthocell and Spineology across arthroscopy/soft tissue repair, joint reconstruction, orthobiologics, spine and trauma.... Read more »

Think Different About Management Reviews

by John Gagliardi | Jun 2018

When done correctly—with preparation and an energized approach—these reviews can complement strategic planning and measure the effectiveness of your QMS in relation to your business model.... Read more »

Making a Device Design Change? Document These Critical Steps

by EduQuest Staff | Jun 2018

No matter where you are in the design process and no matter your internal procedures, control and documentation of design change is critical for safe and effective products.... Read more »

Zimmer Biomet Responds to FDA Form 483

by Julie A. Vetalice | Jun 2018

The company stated disagreement with certain aspects of some of the technical CAPA topics, based on perceived misunderstanding on behalf of the investigators, a lack of context and incomplete information reported by company representatives.... Read more »

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

by Julie A. Vetalice | Jun 2018

To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first orthopaedic FDA 510(k) clearances.... Read more »

Why the Inadvertent Release of Non-Conforming Products is Reportable, Recordable

by EduQuest Staff | May 2018

It is recommended to err on the side of caution in these situations and report the product release, as well as record any internal corrections.... Read more »

Protecting Your Design with Patents

by Andrew Rapacke | May 2018

A smart legal strategy is to develop a comprehensive intellectual property portfolio of the various diverse—but related—IP rights associated with the inventive device.... Read more »

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by John Gagliardi | Apr 2018

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. ... Read more »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by John Gagliardi | Feb 2018

Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can take several steps to minimize these mistakes — it comes down to being in control.... Read more »

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by Rob Meyer | Feb 2018

The rule amends that inspections will be risk-based, not biennial.... Read more »

UDI: Is Your System Ready for Scale?

by Carolyn LaWell | Jan 2018

UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval.... Read more »

FDA Issues First De Novo Clearance Under Orthopaedic Panel

by BONEZONE | Jan 2018

IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures.... Read more »

The Brazilian Market: A Regulatory Overview for Orthopaedic Products

Most Brazilian surgeons use imported products, making the country attractive for international companies. Placing products on the market means creating relationships with Brazilian companies and understanding orthopaedic-specific regulations.... Read more »

FDA Releases Priorities for 2018

by Rob Meyer | Jan 2018

Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices.... Read more »

FDA Finalizes Additive Manufacturing Guidance

by Carolyn LaWell | Dec 2017

FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.... Read more »

Examining Methods to Determine Sample Sizes

by Deborah Munro | Dec 2017

Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics.  ... Read more »

Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance and safety.... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by John Gagliardi | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.   ... Read more »

UDI Direct Marking Guidance Finalized by FDA

by Rob Meyer | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »

DT MedTech Receives 510(k) Clearance for Hintermann Total Ankle

by BONEZONE | Nov 2017

The Hintermann Series H2 is a semi-constrained cemented prosthesis for primary or revision surgery, also indicated to treat failed total ankle replacement or non-union/mal-union of the ankle arthrodesis.... Read more »

Your EU Medical Device Regulation Guide

by Deborah Munro | Oct 2017

Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the Medical Device Regulation MDR 2017/745.... Read more »

CAPA Notes from an FDA Inspection

by John Gagliardi | Oct 2017

Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the inspector and the medical device manufacturer.... Read more »

The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

by Julie A. Vetalice | Aug 2017

Globus Medical has received clearance for its first two trauma products. While they prepare to enter that space, numerous competitors are bringing out interbody fusion devices for introduction in U.S.   ... Read more »

Trauma and Spine Gain New Players with First 510(k)s in 1H17

by BONEZONE | Aug 2017

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to our scan of FDA’s database. Nine of the 23 510(k)s were in trauma and seven in spine.... Read more »

Hip and Spine: New Players Receive FDA 510(k)s

by Julie A. Vetalice | Jul 2017

Of the 56 orthopaedic-related 510(k)s that FDA released in June, we share observations and insights on two total hips, one interbody fusion system and a pedicle screw system.... Read more »

Reimbursement Tips: Four Things Payors Want

by Julie A. Vetalice | Jul 2017

The complexity of reimbursement may be great, but the burden may be lessened if you begin with the end in mind—and know what you’re up against—and make good choices throughout the process.... Read more »

May 510(k) Review: New Players in SI Joint Fusion, Hip Recon

by BONEZONE | Jun 2017

Of 56 products gaining clearance under FDA's Orthopedic Panel in May, we highlight the following four: a locking plate, next-gen meniscus repair implant, SI joint fusion device and new total hip.... Read more »

Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

by John Gagliardi | Jun 2017

While no company expects to undergo a FDA recall, preparatory steps can decrease the costly and lengthy process of removing product from the market. Begin by knowing the leading causes of recalls.... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit

by John Gagliardi | May 2017

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.&... Read more »

When Do I See a CAPA Specialist?

by Denise Dion | May 2017

If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we differentiate between complaints, non-conformances and CAPAs? Our experts respond.... Read more »

FDA 510(k) Insights: March Clearance Highlights

by BONEZONE | Apr 2017

Strategic FDA 510(k)s released in March 2017 include a cannula from AJU Pharm, Bodycad's uni knee, a new company from Surgical Frontiers' portfolio and a revision system from MicroPort Orthopedics.... Read more »

Clinical Data and CE Mark: What are We Doing Wrong?

by Carolyn LaWell | Mar 2017

A reader informed us that companies are failing the clinical evaluation portion of the initial CE Mark or audit process, and asked what insights we might offer now and at OMTEC. Here's our response.... Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.... Read more »

FDA Update: Final Guidance on Medical Device Reporting

by BONEZONE | Jan 2017

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner.... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by John Gagliardi | Jan 2017

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks.... Read more »

One Answer to Your Postmarket Challenge: Planning

by Julie A. Vetalice | Dec 2016

Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start.... Read more »

Building Your Bridge to the Island of ISO 13485:2016

by John Gagliardi | Nov 2016

Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed. There... Read more »

Clinical Data: A Snapshot of Recent Announcements

by BONEZONE | Nov 2016

Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company. Wherever your responsibilities lie within your company, it’s important to consider how your work contributes to better patient outcomes, and know ... Read more »

Spine Company 510(k)s from 1H16

by Julie A. Vetalice | Oct 2016

Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering.... Read more »

Reimbursement in Spine: A NASS Priority

by Julie A. Vetalice | Sep 2016

In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline.... Read more »

Resubmitting a 510(k) is More Than a Regulatory Decision

by John Gagliardi | Sep 2016

Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them.... Read more »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

Cartiva Receives FDA PMA for Synthetic Cartilage Implant

by BONEZONE | Jul 2016

Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval.... Read more »

FDA Guidance Outlines How to Create a Unique Device Identifier

by Carolyn LaWell | Jul 2016

FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier.... Read more »

How to Register Your Device in Australia

by Chris Mosby | Jul 2016

This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking in the process.... Read more »

3 Points to Consider from the Long-Awaited EU Medical Device Regulations

by Hannah Corcoran | Jul 2016

The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe.... Read more »

Third Party Reviews – Is This the Real Deal?

by John Gagliardi | Jun 2016

Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and instead utilize the Third Party Review program. The benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) ... Read more »

Trade Secrets Go Federal

by John W. Boger, Esq. | Jun 2016

Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law. One of the key aspects of DTSA is that companies will now be allowed to file civil lawsuits in Federal court if their trade secrets have been stolen, possibly creating a new level of consistency in how trade secret la... Read more »

Invibio Settles FTC Antitrust Allegations Concerning PEEK Market

by BONEZONE | May 2016

Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it violated antitrust law by using long-term, exclusive contracts to maintain a market monopoly.... Read more »

FDA Issues Draft Guidance on Additive Manufactured Devices

by Carolyn LaWell | May 2016

FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among the top concerns of FDA and industry are post-processing, cleaning and sterilizing devices.... Read more »

Supplier Quality Agreements Are Not Just a Handshake Anymore

by John Gagliardi | Apr 2016

Regulatory bodies do not see supplier quality agreements as a new requirement. They also expect medical device manufacturers to require suppliers to conduct remediation where required and within documented timelines. It is appropriate to use a risk management approach to prioritize required focal po... Read more »

FDA Releases UDI Education as Deadline Approaches

by BONEZONE | Apr 2016

FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources include slideshow presentations and video interviews with FDA.... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

Proving Medical Necessity: the Need for Evidence in Reimbursement

by BONEZONE | Mar 2016

Providers, OEMs and suppliers all say that they’ve been impacted by complexities in the reimbursement system. For example, bundled payments and an increased burden of evidence have changed the way that products are developed and launched. One theme has arisen from the many conversations—not a ne... Read more »

New Guidance for UHMWPE Submissions

by BONEZONE | Feb 2016

FDA recently released draft guidance outlining new information companies must include when submitting devices with Ultra High Molecular Weight Polyethylene (UHMWPE) for approval. ... Read more »

The Revitalized ISO 13485: Ready for Business

by John Gagliardi | Feb 2016

The ISO 13485:2016 Standard is slated for publication in March 2016. Consider these eight changes when updating your certification.The internationally-recognized medical device industry quality management systems (QMS) standard has been under revision since 2010. The newest version of ISO 13485 (201... Read more »

A Look at FDA’s 2016 Priorities, Status of 2015 Priorities

by BONEZONE | Jan 2016

FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH is accepting feedback as part of its retrospective review.... Read more »

UDI Update: Trays and Kits

by BONEZONE | Jan 2016

FDA released draft guidance for its Convenience Kit exemption, offering orthopaedic device manufacturers more direction on labeling device trays and kits with unique identifiers (UDIs). The proposed change would clarify the definition of convenience kit, reducing the number of accepted exemptions an... Read more »

Adaptive Designs Provide Clinical Trial Flexibility

by Hannah Corcoran | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

UDI Ruled a Requirement for EHRs

by BONEZONE | Dec 2015

A final rule issued by the Office of the National Coordinator for Health IT of the U.S. Department of Health and Human Services will require providers to incorporate UDIs into electronic health records, allowing providers to track devices used by their patients at any point of care.... Read more »

Harvesting Engineers’ Ideas through Invention Disclosure

by John W. Boger, Esq. | Dec 2015

The key precursor to the development step is the “harvesting effort.” Answering specific questions allows inventors to organize their thoughts and give a clear explanation about their invention.... Read more »

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | Nov 2015

FDA’s Center for Devices and Radiological Health (CDRH) plans to embrace the use of big data and patient reported outcomes in regulatory decision making, according to its 2016 Regulatory Scientific Priorities.... Read more »

3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers

by Hannah Corcoran | Nov 2015

Additive manufacturing and the domination of digital communication and information transfer pose new concerns for manufacturers.... Read more »

Product Development and IP Considerations: A Marriage Made in Heaven?

by John W. Boger, Esq. | Sep 2015

This article outlines the stages of the R&D process and the corresponding parallel issues that the legal department would want addressed either prior to or at the same time.... Read more »

FDA Outlines Critical Quality Measures

by BONEZONE | Sep 2015

FDA’s Director of the Division of Manufacturing and Quality discussed recent Agency initiatives that emphasize quality over compliance.... Read more »

CMS Targets Hip and Knee Reimbursement

by BONEZONE | Aug 2015

The U.S. Centers for Medicare & Medicaid Services (CMS) proposed a bundled payments program to accelerate value-based care that, once passed, could impact hip and knee implant pricing.... Read more »

Master Your Sterilization Process

by BONEZONE | Aug 2015

At OMTEC® 2015, Jozef Mastej, Vice President of Operations, Gibraltar Laboratories, Inc. outlined the cleaning and sterilization validation process for reprocessing reusable devices.... Read more »

ISO 9001 Drastically Revised

by Robert Packard | Aug 2015

The ISO 9001:2015 standard is a major revision that will require significant time and resources to determine the best way to implement the revised quality system. Most companies will need all three years of the transition period for compliance.... Read more »

The Dos and Don’ts of Trademark Registration

by John W. Boger, Esq. | Aug 2015

The investment of time and money to obtain trademarks may take a significant hit if the respective trademarks are not properly used and noted. This article serves to suggest best practices regarding a company’s use of its trademarks.... Read more »

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

by BONEZONE | Jul 2015

FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing for the September 24, 2015 compliance deadline.... Read more »

Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s

by Hannah Corcoran | Jul 2015

Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions.... Read more »

FDA Outlines Stance on ex-U.S. Clinical Data

by Hannah Corcoran | Jun 2015

In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval in in the U.S.... Read more »

FDA Launches Searchable UDI Database

by BONEZONE | Jun 2015

FDA recently announced the launch of AccessGUDID, a website that allows users to search and download information on devices that require identification.... Read more »

Mobile Medical Apps Attract OEM, FDA Attention

by Prithul Bom, MBA, RAC | Jun 2015

Mobile communication devices are radically changing the way we think and make decisions about our healthcare. Manufacturers developing medical mobile applications must understand FDA’s regulatory stance.... Read more »

Training Your IP Police Force to Catch Infringement

by John W. Boger, Esq. | May 2015

It is critical for all companies to establish and properly train their own IP police force to enforce their own protected inventive designs.... Read more »

Big Changes in ISO 13485:2015?

by Robert Packard | May 2015

On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new quality system requirements in the latest version of ISO 13485 affect you?... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2015

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.... Read more »

CDRH Proposes Nationwide Postmarket Surveillance System

by BONEZONE | Apr 2015

The Center for Devices and Radiological Health has proposed a National Medical Device Postmarket Surveillance System expected to serve the needs of patients, clinicians, payors and manufacturers.... Read more »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 2015

When non-conformity is identified, your company must determine the significance, the associated risk and the potential for recurrence. Manufacturers must determine a common denominator that helps with the decision-making.... Read more »

You Secured a Utility Patent; Now What about Your Design Patent?

by John W. Boger, Esq. | Mar 2015

Recent high-profile lawsuits have demonstrated the importance of design patents to protect inventions. Understand the difference between a design and utility patent to ensure that your IP portfolio is appropriately armed against attack.... Read more »

The Basics: Understanding the Medical Device Single Audit Program

by Robert Packard | Feb 2015

MDSAP was launched to leverage resources of regulatory bodies in the U.S., Canada, Brazil and Australia to monitor device manufacturers. Here is a breakdown of how the pilot program works and each country’s participation.... Read more »

CAPA+2, UDI and More: What to Expect from FDA in 2015

by Hannah Corcoran | Feb 2015

Ensure that you’re prepared for FDA’s 2015 plans. Keep your compliance in check with this expert perspective.... Read more »

Actions Underway in a Push to Repeal the Medical Device Tax

by BONEZONE | Jan 2015

With support from both major parties, U.S. legislators have introduced bills in renewed attempts to repeal the medical device tax.... Read more »

Compliance Isn’t Accidental: A Case for Management’s Commitment to Quality

by John Gagliardi | Jan 2015

Leadership must foster a culture of business and quality equilibrium to drive long-term product and company success. That commitment involves proper planning, employee training and performance measurement.... Read more »

FDA Publishes Priorities for 2015

by BONEZONE | Jan 2015

FDA’s Center for Device and Radiological Health issued its list of priorities for 2015, including guidance documents it intends to publish and other initiatives.... Read more »

Why Won’t My CAPA Process Work?

by John Gagliardi | Dec 2014

Having a viable CAPA process in place is critical, in a time of frequent recalls, increased warning letters for repeat offenders and burdensome reporting requirements.... Read more »

Unique Device Identification (UDI): Many Questions Remain

by Karen Conway | Dec 2014

FDA issued its final rule requiring medical device manufacturers to assign and label products with UDIs more than a year ago. However, many questions remain for orthopaedic and spine manufacturers.... Read more »

How to Get the Most Out of Your IP Firm

by John W. Boger, Esq. | Dec 2014

Device companies often mistakenly focus solely on patents to protect their ideas. Taking this narrow approach could hurt the long-term growth of the company.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2014

Discover which orthopaedic companies recently received strategic FDA 510(k) clearances to market their products.... Read more »

FDA Extends UDI Compliance Date for Certain Orthopaedic Implants

by BONEZONE | Dec 2014

A variety of fixation screws, plates and spinal devices will not need to meet UDI labeling requirements until 2016.... Read more »

Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations

by Carolyn LaWell | Nov 2014

While the EU has yet to set a completion or implementation date for spine implant reclassification, manufacturers shouldn’t wait to prepare.... Read more »

FDA Focuses on Properties and Biocompatibility of AM Medical Devices

by Hannah Corcoran | Nov 2014

Understand FDA’s current thinking on the regulatory process for additive manufactured devices.... Read more »

FDA Surveillance Inspections and Warning Letters Decrease

by Hannah Corcoran | Nov 2014

A CDRH quality system data report offers insight into common observations from 2013. Familiarize yourself with these trends and action items to avoid quality issues.... Read more »

FDA Addresses Custom Device Exemptions

by Hannah Corcoran | Nov 2014

FDA clarified changes to the Custom Device Exemption provision through a final guidance document.... Read more »

FDA Seeks 21st Century Agility with 510(k)s

by John Gagliardi | Oct 2014

FDA introduced several changes, including new initiatives to clarify the 510(k) submission process. How will these changes affect your device’s pathway to market clearance?... Read more »

Can I Make, Use and Sell My Patented Invention? The Answer May Surprise You

by John W. Boger, Esq. | Oct 2014

Obtaining a patent does not always guarantee the ability to build and commercialize your invention. Follow these tips to avoid infringement and ensure success.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2014

See which orthopaedic companies recently received 510(k) clearances to market their products.... Read more »

FDA Publishes Q&A on UDIs

by BONEZONE | Sep 2014

The deadline for Unique Device Identifier (UDI) implementation for medical devices is September 24, 2014. FDA has issued a 14-page Q&A document to help manufacturers prepare.... Read more »

Experts Offer Strategies for Clinical Trial Execution and Outsourcing

by Hannah Corcoran | Sep 2014

Experts share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as well as ways to manage outsourcing of the process to a partner.... Read more »

FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

by Justin Rowland | Sep 2014

FDA attempts to clarify substantial equivalence requirements in its latest 510(k) guidance. What do these changes mean for your next submission?... Read more »

Choosing Materials in a Shifting Global Regulatory Environment

by BONEZONE | Aug 2014

Orthopaedic device manufacturers face increasing pressures related to the safety of raw materials used in implants and instruments. Consider these factors when determining material utilization for a new product.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those companies receiving first clearance for an orthopaedic product. ... Read more »

Effective Tools for Patent Searches

by BONEZONE | Jul 2014

Management has given the go-ahead to design a new device. As an engineer, you’ll now conduct a patent search to ensure that your technology won’t infringe upon other patents. What tools—free or otherwise—should you use to ensure that your search is comprehensive?... Read more »

Protecting Inventions and Brands: IP Due Diligence in the Product Development Process

by John W. Boger, Esq. | Jun 2014

The importance of IP due diligence is often overlooked when bringing an orthopaedic device through each of the eight stages of product development.... Read more »

UDI Implementation: What are Your Next Steps?

by Jonathan Bretz | Jun 2014

Creating a playbook or strategic plan is an absolutely necessary step of UDI implementation. The major components of your plan should include these steps.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Arthrosurface, Ellipse Technologies, Extremity Medical, Flower Orthopedics, MTP Solutions, Nexus Spine, Prosidyan and Tyber Medical. ... Read more »

How Far is “Possible” for Risk Management?

A controversial interpretation of the medical device CE Marking requires risk reduction without room for economic consideration. This approach conflicts directly with the Essential Requirements of the European Medical Device Directives. In order to comply, manufacturers need to carefully review proc... Read more »

Five Steps to Regulatory Strategy Development

by Mark D. Kramer, RAC | Mar 2014

Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Benvenue Medical, Edge Orthopaedics, Integrity Spine, Lanterna Medical Technologies, Mikron Makina, MTP Solutions, Toby Orthopedics, Virak Orthopedic Research. ... Read more »

Five Ways to Prevent Complaint Handling Pitfalls

by Robert Packard | Mar 2014

Learn how to avoid receiving 483s from other's previous mistakes. This article analyzes the five most common 483s related to 21 CFR 820.198, reviews what FDA inspectors typically find that results in a 483 and what FDA inspectors hope to find.... Read more »

3D Printing and IP: Can They Coexist?

by John W. Boger, Esq. | Mar 2014

Analysts have predicted that by 2018, 3D printing will result in a loss of $100 billion per year in IP globally. Here is a look at why enforcing one’s IP against 3D printer infringers will be challenging.... Read more »

CDRH 2014-2015 Priorities Focus on Clinical Trials and PMAs

by BONEZONE | Feb 2014

CDRH's 2014-2015 Strategic Priorities address the difficulty that manufacturers face in seeking and obtaining regulatory approvals.... Read more »

FDA Publishes List of Priorities for 2014

by BONEZONE | Jan 2014

FDA’s Center for Device and Radiological Health issued a list of guidance documents that it intends to publish in FY2014. The topics that might be of interest to orthopaedic device companies include the following.... Read more »

FDA Posts 510(k) Communication Timeline

by BONEZONE | Jan 2014

FDA has developed a timeline that provides 510(k) applicants with an understanding of communication during the review process.... Read more »

FDA Promotes Voluntarily Correcting Violations with New Program

by BONEZONE | Jan 2014

FDA recently announced details of a new pilot program that will allow medical device companies to voluntarily identify and correct regulatory violations rather than undergo FDA inspection.... Read more »

The Hague Agreement: It May Save You Money

The Hague Agreement more closely aligns U.S. design patent laws with the international community. It also provides flexibility when filing and can save money. There are a few notes of caution to consider, though.... Read more »

U.S. OIG Issues POD Report; Reliance Medical Files a Suit

by BONEZONE | Dec 2013

The U.S. Office of Inspector General of the Dept. of Health and Human Services' overview of prevalence and use of physician owned distributors (PODs) of spinal devices does not make specific recommendations for action, but notes that in FY11, PODs supplied devices used in ~1 in 5 spinal fusions bill... Read more »

National Joint Registry for England, Wales and Northern Ireland: Findings from 10th Annual Report

by BONEZONE | Dec 2013

The NJR Steering Committee launched its tenth report in late September. Data from more than 1.4 million procedures are now registered with considerable growth expected now that elbow and shoulder replacement data collection is underwayand Northern Ireland has joined the NJR . The report also contain... Read more »

CMS Issues Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

by BONEZONE | Dec 2013

The U.S. Centers for Medicare & Medicaid Services proposes that Percutaneous Image-guided Lumbar Decompression for lumbar spinal stenosis is not reasonable and necessary. Therefore, CMS proposes that PILD for LSS is non-covered by Medicare.... Read more »

Start Early: Converting Your Spinal Technical File into a Class III Design Dossier

by Robert Packard | Dec 2013

As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Altus Spine, Anchor Innovation, Beijing Libeier Bio-Engineering Institute, Binder Biomedical, Corentec, Elite Surgical, Innovative Surgical Designs, Intelligent Implant, Jeil Medical, NovoSource, Tybe... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Nov 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Binder Biomedical, Corentec, Jeil Medical, NovoSource, ORTHOSoft, Renovis Surgical, Tyber Medical, Vertebral Technologies.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2013

The following companies recently received strategic FDA 510(k) clearances: Advanced Interventional Technology, CoreNexus, Crosstrees Medical, Emerge Medical, Ingen Orthopedics, JG Spine, Next Orthosurgical, Osseus Fusion Systems, Shanghai Sanyou Medical and Vivorte.... Read more »

Mitigate Patent Infringement Risk with an FTO

by John W. Boger, Esq. | Oct 2013

Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how to execute the three-stage process.... Read more »

Presenting Data to Show Product Cost Effectiveness

by Isabella Sledge, M.D. | Oct 2013

Shifts in the marketplace are driving a need to collect and position clinical data in order to show product effectiveness. OEMs can successfully commercialize new technologies by adopting these measurements.... Read more »

FDA Finalizes UDI Requirements

by BONEZONE | Sep 2013

Final rule does not mandate direct part marking for implantable devices, provides manufacturers of Class III implants one year to comply.... Read more »

How to Choose a Notified Body

by BONEZONE | Sep 2013

The right Notified Body will support device manufacturers in accomplishing current and long-term goals. Here are questions to ask and trends to consider when searching for the right partner.... Read more »

Postmarket Studies in Lieu of Clinical Trials

A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue sooner.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Pantheon Spinal, Pinnacle Spine, Spine Wave, Synergy Biomedical, X-Spine Systems. ... Read more »

How to Avoid Major FDA Inspection Mistakes

by Robert Packard | Jul 2013

Don’t let these details get lost in the preparation and follow up for FDA inspections.... Read more »

UDI Update: Prepping for the Final Ruling

by Karen Conway | Jul 2013

OEMs should be asking, and answering, these 11 questions in anticipation of FDA’s final ruling on UDI guidelines.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2013

The following companies recently received strategic FDA 510(k) clearances: Apogee OrthoSolutions, Biomedical Enterprises, Cleveland Clinic/Custom Orthopaedic Solutions, Institute of Musculoskeletal Science & Education, Metasurg, NovoSource, NUTEK Orthopaedics, Pantheon Spinal, Providence Medical... Read more »

The Race to the Patent Office Is On

New regulations have converted U.S. patent law from a “first-to-invent” to a “first-inventor-to-file” system. These best practices will ensure you or your company don’t miss out on intellectual property.... Read more »

Seven Ways to Investigate Complaints When Devices Aren’t Returned

by Robert Packard | Jun 2013

One of the challenges in product complaint handling is making sure you’ve done enough when you’re unable to verify the complaint. These steps lead to a successful investigation process.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen Medical, Facet-Link, Flower Orthopedics, Global Manufacturing Technology, Kalitec Direct, Maxim Surgical, Myelotec, Orthopaedic Implant Company... Read more »

Navigating the Clinical Research Paradigm for Cost Savings and Efficiencies

by Marcy Rogers | May 2013

By working effectively through the timelines and deliverables from reimbursement, the regulatory pathway, data requirements and clearance, companies can bring their orthopaedic devices to market on schedule, on budget and in regulatory compliance.... Read more »

Design Control Hot Buttons to Expect During an FDA Inspection

by John Gagliardi | May 2013

FDA evaluates the methods and procedures that a manufacturer has established to implement design control requirements. During an inspection, attention is turned to these design linkages.... Read more »

Six Steps to ISO 13485 Certification

by Robert Packard | May 2013

ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a roadmap to certification.... Read more »

What if Your ISO Auditor is Wrong?

by Robert Packard | Apr 2013

Auditors are human. The question is: What should you do when they're wrong?... Read more »

Just Because You’re Trained, Doesn’t Mean You’re Competent

by John Gagliardi | Apr 2013

Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination for each person and then create a plan to close those gaps.... Read more »

Strategic Orthopaedic 510(k) Update

by BONEZONE | Apr 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen Medical, Flower Orthopedics, Global Manufacturing Technology, Kalitec Direct, Maxim Surgical, Myelotec, Orthopaedic Implant Company, Orthopro, ... Read more »

Get Ready for UDI: It’s All About the Data

by Karen Conway | Mar 2013

Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex nature of UDI means OEMs can’t wait for the final announcement to put processes in place.... Read more »

FDA Releases New Requirements for Combination Products

by BONEZONE | Mar 2013

FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements.... Read more »

Trademarks vs. Domain Names, Part II: There is a BIG Difference

by John W. Boger, Esq. | Feb 2013

What happens if your trademark or company brand becomes a victim of cybersquatting? Part II on trademarks vs. domain names provides legal steps that can be taken to protect you or your company's name.... Read more »

Rethinking the Role of Clinical Affairs

by Joel Batts | Feb 2013

“Clinical” has become virtually synonymous with Investigational Device Exemption and Premarket Approval. Really, clinical affairs should be viewed as a multi-related, multi-obligated team that collectively defines an OEM.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Feb 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Camber Spine, Eleven Blade Solutions, K7, LSK BioPartners, Metric Medical Devices, Stanmore Implants... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jan 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: B2B Spine, Brainlab, Christopher D. Endara, Emerge Medical, Everest Spine, Fairway Medical, Foundry (Newco XI), Frontier Medical, InSurgical, NCS Lab, Ouroboros Medical, Stabiliz Orthopaedics, Z-Medic... Read more »

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

by Martin Browning | Dec 2012

FDA’s multi-layered rules for product recalls can resemble a double-edged sword. Have you under-reported your recall? Over-reported? How can you find middle ground and ensure compliance? Martin Browning proposes a 4-step decision process.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alliance Spine, Aston Medical, Iconacy Orthopedic, Implanet, Intelligent Implant Systems, Osseon Therapeutics, Providence Medical, Safe Orthopaedics, Shanghai Kinetic, Shoulder Options, Weigao Orthopa... Read more »

Trademarks vs. Domain Names, Part I: There is a BIG Difference

by John W. Boger, Esq. | Dec 2012

What happens if there is a dispute over the use of your domain name, or if someone is using your trademark as a domain name? It’s tempting to lump both under the heading “cybersquatting,” but they are not. Cybersquatting is the act of registering, selling or using a domain name with the intent... Read more »

The IPXI® - An Alternative to the License Agreement? Maybe!

by John W. Boger, Esq. | Oct 2012

  Monetizing intellectual property is the process of deriving tangible value from the IP or the technology that is protected by the IP. Currently, however, there are only a limited number of ways of deriving such value. For example, monetizing a patent usually follows one of two paths: 1) deri... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Accel SpineMatisse Anterior Cervical Interbody Fusion Cage, K121569*•... Read more »

The IP License Agreement: A View from 5,000 Feet

by John W. Boger, Esq. | Aug 2012

It is commonplace for medical device manufacturers to “license” technology to allow them to either manufacture, sell or develop a product. Licensing of patents, trademarks, copyrights or trade secrets (collectively, intellectual property or IP) from third parties is governed by a special kind of... Read more »

Medicare: Trends in Beneficiaries Served and Hospital Resources Used in Implantable Medical Device Procedures

by BONEZONE | Aug 2012

Results from a U.S. government agency report summarize data on average length of stay, patient characteristics, discharges, etc. Highlights include: In the U.S. in 2009, knee, hip and shoulder replacement and lumbar fusion procedures accounted for 98% of Medicare's orthopaedic implantable device ... Read more »

The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up

by Hamish Forster | Aug 2012

In my previous BONEZONE article, “Basic Anatomy of a Design Dossier” (BONEZONE March 2011), I presented an overview of the key elements required within technical documentation in order to demonstrate conformity to the Medical Device Directive (MDD) 93/42/EEC. A key requirement is post-market su... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. CitieffeExternal Fixator, K113384 For knee or elbow applications Fo... Read more »

Building a Basic Good Clinical Practice Foundation to Weather the Storm

OMTEC 2012 opening panel presenters, consisting of David Floyd, Bill Plovanic, Bill Kolter and Brian Moore, painted a compelling picture of the current status and upcoming challenges facing the orthopaedic industry.  According to the panel, orthopaedic sales, which saw a decline in 2010, now ap... Read more »

The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies

by John Gagliardi | Jun 2012

This is the second of two articles dealing with the FDA Warning Letter, in which we’ll look at actual letter excerpts with recommended strategies to respond to FDA in a compliant and effective manner. As discussed in the prior article (See BONEZONE, March 2012), when FDA finds that a manufacturer ... Read more »

Trademark Searches and Availability Opinions

by John W. Boger, Esq. | Jun 2012

Branding of products and services is the key to success for almost any medical device company. For example, the NexGen® Knee by Zimmer, Rapid Recovery® Services offered by Biomet and the X-Stop® IPD® System owned by Kyphon are all well-recognized brand names in the orthopaedic marketplace. If th... Read more »

The Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership

by BONEZONE | Jun 2012

Grace College shares an address with a $38 billion global industry in Warsaw, Indiana, the orthopaedic capital of the world. Today, device innovators like Biomet, DePuy and Zimmer are also getting into the business of education—out of necessity. The Lilly Endowment, an Indiana-based foundation th... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Ascendx Spine Acu-Cut Vertebral Augmentation System, K113452 For use... Read more »

Daily Documentation Essentials: A Tour of the Regulatory Binder

The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority. Historical precedent... Read more »

The Anatomy of a Warning Letter, Part One: A Primer

by John Gagliardi | Mar 2012

This is the first of two articles dealing with the dreaded Food & Drug Administration (FDA) Warning Letter. This first article is an introduction, if you will, to Warning Letters. The second article will contain actual warning letter excerpts with a recommended strategy to respond to FDA in a co... Read more »

An Introduction to Patent Opinions

by John W. Boger, Esq. | Mar 2012

Whenever a medical device company develops a new product, process or technology, the topic of getting an “opinion” inevitably arises. Many different types of patent or Intellectual Property (IP) opinions exist, each one with a specific purpose. If one were to follow the typical product developm... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Arrowhead Medical Device TechnologiesArrow-Lok Digital Fusion System, K... Read more »

510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies

In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data.... Read more »

IP Portfolio Management Strategies for Medical Device Manufacturers

by John W. Boger, Esq. | Dec 2011

Management of a company’s intellectual property (IP) is all about two things: controlling the innovation produced by the Research and Development (R&D) staff and transforming these ideas in valuable assets, and coordinating the R&D innovation output with the sales and marketing strategy of... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2011

The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Algea TherapiesAffirm Vertebral Compression Fracture System... Read more »

Final Office Action Rejections for Patent Applications: It Ain’t Over until the Fat Lady Sings…Usually

by John W. Boger, Esq. | Oct 2011

The patent process can be a long and, at times, tedious process. Many inventors assume that once you file your application with the United States Patent and Trademark Office (USPTO), the hard work is done. Unfortunately, for most cases, the hard work has just begun. It is highly unusual for a patent... Read more »

The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?

by Kelli Hallas | Oct 2011

Readers: After this story was published, FDA and CMS launched a Pilot Program for Parallel Review of Medical Products. Current information can be found on FDA's web site. −Editor   Medically necessary vs. safe and effective. Can clinical trials, by design, realistically satisfy the needs ... Read more »

BSI Enhances its Medical Device Training Curriculum with RABQSA

by BONEZONE | Oct 2011

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... Read more »

The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

by Martin Browning | Aug 2011

Agency Announces Five Key Priorities over Next Five Years Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan that could have far-reaching consequences for the medical device industry. In late April 2011, FDA Commis... Read more »

The Reimbursement Top Ten Checklist: Understanding How Coverage, Codes and Payment Impact the Success of a New Medical Technology

by Kelli Hallas | Jun 2011

The product design is flawless. The clinical trial endpoints were met. FDA has given the green light to begin marketing. Manufacturing has ramped up and can accommodate distribution deadlines. The plan is perfect; what could possibly go wrong? Bottom line is this…no matter how unique or innovativ... Read more »

Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace

by Mary Fautsch | Jun 2011

The medical device industry faces a number of significant challenges. Federal health care reform, unpredictable U.S. regulatory pathways and an uncertain economic climate are exerting a tremendous amount of pressure on the entire industry. Various segments of the orthopaedic market have been hit esp... Read more »

Patent Reform is On the Way…Maybe

by John W. Boger, Esq. | Jun 2011

For the past several years, Congress has debated several bills that would change the way that patent laws are currently written. The amendments that have been discussed would have significantly changed the way companies, both big and small, do business. The major stumbling block for all past failed ... Read more »

Basic Anatomy of a Design Dossier

by Hamish Forster | Mar 2011

This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity to the Medical Device Directive 93/42/EEC (MDD). It is intended to provide an overview for regulatory professionals who seek to compile technical ... Read more »

Beware of the Falsely Patent Marking Boogey Man

by John W. Boger, Esq. | Mar 2011

Within the past 18 months, a cottage industry has started to emerge.  This disruptive industry exists to sue companies for allegedly mismarking products or packaging with expired or incorrect patent numbers. Importantly to the readers of BONEZONE, the reach of these “entrepreneurs” has touc... Read more »

Notified Body Requirements for Clinical Literature Evaluation

by Amie Smirthwaite | Dec 2010

The most recent revisions to the European medical devices directive have underlined the importance of clinical data in demonstrating compliance to the Essential Requirements. The first step in this process is the clinical literature evaluation, for which there are three key sources of guidance: ISO ... Read more »

Clinical Strategy Review for CE Marking

by Gert W. Bos, Ph.D. | Dec 2010

The Notified Body British Standards Institution (BSI) has launched the Clinical Strategy Review for manufacturers applying for CE marking. (See Exhibit 1.) This new service helps manufacturers ensure ahead of time that their clinical evaluation plan will be acceptable to meet the regulatory requirem... Read more »

Review of Study Results: FDA Impact on U.S. Medical Technology Innovation

by Julie A. Vetalice | Dec 2010

FDA Impact on U.S. Medical Technology Innovation, a study released in November 2010, was undertaken to provide a view of medical technology (medtech) industry’s experiences with the current FDA environment. The study addressed the need for quantitative and qualitative data to help evaluate the imp... Read more »

You May Own a Copyright and Not Know It!

by John W. Boger, Esq. | Dec 2010

Copyrights are rampant in the world of orthopaedics and are, most of the time, ignored or forgotten. Copyrights can be quite valuable intellectual property to both an individual and a company and, if used strategically, can provide an immensely competitive edge. Works that are protectable under copy... Read more »

MDD Regulations: What I Wish I Had Known

by Laurel Macomber, M.S. | Sep 2010

Having worked in medical device research and development for over 20 years, I have contributed to many regulatory submissions for both the U.S. and European Union (EU) markets. However, now, as an EU Notified Body technical reviewer, I’ve found that there are many things I wish I had known previou... Read more »

Truth or Myth: Does an International Patent Exist?

by John W. Boger, Esq. | Sep 2010

Almost every inventor has asked, “Can I get an international patent?” The simple answer is, no. Let’s be clear, there is no such thing as an international patent. However, an inventor can file an “international patent application” that essentially takes the place of the many individual fo... Read more »

Pssst…It’s a Secret…Don’t tell anyone!!!

by John W. Boger, Esq. | Jun 2010

Remember back to your youth when keeping secrets was an everyday occurrence? Sometimes it was between classmates or siblings, and the results of not keeping it were temporary. As one grew older, keeping secrets took on a more serious tone as the consequences of disclosure usually had a more signific... Read more »

Filing a Provisional Patent Application – Applicant Beware

by John W. Boger, Esq. | Mar 2010

The world changed as we knew it on June 8, 1995, when the United States Patent and Trademark Office (“USPTO”) was required to implement certain provisions from the GATT Uruguay Round Agreements. One of the modifications that occurred as a result of the GATT Agreements was that the lifetime of a ... Read more »