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Articles Tagged "510(k)"

Benvenue Medical Gains FDA Clearance for Luna XD MIS Expandable Interbody

by BONEZONE | 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 »

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

by BONEZONE | 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 »

THINK Surgical Completes Enrollment for Study of Active Robot for TKR

by BONEZONE | 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 BONEZONE | 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 »

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

by BONEZONE | 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 BONEZONE | 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 510(k) Recap: Adjacent Markets, Additive, Surgical Platforms

by BONEZONE | 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 Clears First Implant with Molybdenum Rhenium Superalloy

by BONEZONE | 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 BONEZONE | 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 »

CurvaFix Receives FDA 510(k) Clearance for CurvaFix Rodscrew

by BONEZONE | 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 »

SIG Medical Gains Additional FDA Clearance for AdvantageRib System

by BONEZONE | 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 »

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

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

by BONEZONE | 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 »

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

by BONEZONE | Sep 2018

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 »

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

by BONEZONE | 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 »

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

by Julie 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 »

Gauthier Biomedical Gains FDA Clearance for Intellitorq Electronic Torque Indicating Driver

by BONEZONE | Mar 2018

The company is the first to receive 510(k) clearance for an electronic torque indicating device.... Read more »

FDA Releases Priorities for 2018

by BONEZONE | Jan 2018

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

Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA VBR

by BONEZONE | Dec 2017

This is reportedly the first PEEK-OPTIMA HA vertebral body replacement to receive FDA clearance.... 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 »

MicroPort Orthopedics Launches Procotyl Prime Acetabular Cup

by BONEZONE | Sep 2017

MicroPort Orthopedics launched the Procotyl Prime acetabular cup, the next step in the evolution of the Dynasty Acetabular Cup System. The device received FDA 510(k) clearance at the end of 2Q17.  ... Read more »

Globus Medical Receives Clearance for Excelsius GPS

by BONEZONE | Aug 2017

Globus Medical received FDA 510(k) clearance to market their robotic guidance and navigation system, supporting minimally invasive or open orthopaedic procedures including screw placement in spine and orthopaedic surgery.... Read more »

EIT Acquires 3D-Printed Spine Patents

by BONEZONE | Aug 2017

Emerging Implant Technologies acquired a portfolio of 3-D printed expandable spinal fusion cages for vertical and lateral expansion. The first products based on these patents will launch in 2018.... 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 »

ConMed Acquires MedShape’s ACL System to Boost Arthroscopy Portfolio

by BONEZONE | Jul 2017

Revamped marketing and R&D priorities, product launches, recent licensing agreements and now, an acquisition and portfolio expansion with the ExoShape system—all play a part in the company's multi-pronged turnaround initiative. The all-PEEK fasteners fill a gap in the company's offerings.... Read more »

Spine Company 510(k)s from 1H16

by Julie 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 »

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 »

Third Party Reviews – Is This the Real Deal?

by BONEZONE | 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 »

CoorsTek Medical Announces FDA 510(k) Clearance for Total Hip Incorporating CeraSurf-p Implantable Ceramic

by BONEZONE | Mar 2016

CoorsTek Medical's CeraSurf®-p ceramic femoral heads have been incorporated into a U.S. orthopaedic device customer's hip system that has received FDA 510(k) clearance.... Read more »

NASS Recap: Surface-treated, 3D-printed Cages among New Launches in Interbody Space

by Carolyn LaWell | Nov 2015

Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions.... Read more »

Orchid Design Selected to Participate in FDA’s Submission Tracker Pilot Program

by BONEZONE | Aug 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 »

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 »

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 »

3D Medical Concepts Announces FDA 510(k) Clearance of Innovative External Fixation Device

by BONEZONE | Jan 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 »

ECA Medical Instruments Develops 1st Disposable Spinal Instrument Fixation Kit to Gain FDA Clearance with Intelligent Implant Systems

by BONEZONE | Jan 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 »

FDA Publishes Priorities for 2015

by BONEZONE | Jan 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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2014

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 »

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2014

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 »

FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

by Justin Rowland | Sep 2014

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2014

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 »

The Starting Line: Turning the Corner with a Device Concept

by John Gagliardi | Jul 2014

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2014

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 »

Zoning In with Robert Weigle

by BONEZONE | May 2014

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 »

Sterilization: How to Validate Novel and Non-Traditional Processes

by Robert Packard | Apr 2014

Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with traditional sterilization methods. Here is a look at the tools and standards for sterilization validation.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2014

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 »

FDA Publishes List of Priorities for 2014

by BONEZONE | Jan 2014

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 »

FDA Posts 510(k) Communication Timeline

by BONEZONE | Jan 2014

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2013

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Nov 2013

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2013

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 »

Orthopedic Implantable Device made by Maetta Sciences MIM Technology Receives FDA Clearance

by BONEZONE | Oct 2013

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 »

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

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 »

How to Avoid Major FDA Inspection Mistakes

by Robert Packard | Jul 2013

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2013

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2013

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 »

ImageIQ and IMARC Research Announce Innovative Co-Marketing Partnership

by BONEZONE | Apr 2013

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 »

Strategic Orthopaedic 510(k) Update

by BONEZONE | Apr 2013

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 »

Breakthrough in NiTiNOL Use in Implants

by BONEZONE | Feb 2013

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Feb 2013

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 »

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 »

Medical Modeling Receives FDA 510(k) Clearance for Virtual Surgical Planning System

by BONEZONE | Jan 2013

Medical Modeling received FDA 510(k) clearance to market the VSP® System. Initial applications include orthognathics and reconstruction, applying virtual surgical planning in a variety of maxillofacial procedures. (Source: Medical Modeling, Inc.)... 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 »

Z-Medical Receives FDA Clearance for Z-Double Thread Compression Screw

by BONEZONE | Nov 2012

Z-Medical received FDA 510(k) clearance to market the Z-Double Thread Compression Screw for use in foot and ankle applications. The products will be distributed by Nextremity Solutions under the Precision Ready™ brand. (Source: Z-Medical GmbH + Co. KG)... Read more »

FDA Draft Guidance: Refuse to Accept 510(k) Policy

by BONEZONE | Oct 2012

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2012

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 »

Ceram Helps Greatbatch Medical Gain FDA Clearance

by BONEZONE | Aug 2012

Ceram, an independent materials technology company, recently partnered with Greatbatch Medical, providers of critical technologies used in medical devices, to help Greatbatch gain FDA clearance of its hydroxyapatite coating master file by providing all the necessary testing on the coating for a 510(... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2012

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 »

Building a Basic Good Clinical Practice Foundation to Weather the Storm

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2012

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 »

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2012

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 »

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

by BONEZONE | Mar 2012

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 »

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 »

The Benefits of Capturing Product Data Are High - The Costs of Doing So Don’t Have to Be

by BONEZONE | Dec 2010

Co-authored by Keith Kennedy Perhaps more than at any other time in recent years, we are witnessing rapid changes in the way products and procedures are developed and measured in orthopaedics. In addition to innovative product advancements, there is a groundswell of interest in tracking product and... Read more »