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Search Keyword: UDI


Studies Show that Silk Fibroin Material May be Suitable for Interlocking Nails ...

by BONEZONE | Jan 2020 (Supplier News Items) ...  interlocking nail to treat fractures. Silk is made of 75% biocompatible fibroin, a  material with multiple medical applications. Previous studies have shown that fibroin has good biological and mechanica ... Read more »

Thinking Robot Studios Expanding to the U.S. ...

by BONEZONE | Oct 2019 (Supplier News Items) ... Studios (TRS) plans to spend $84 million to construct a new 75,000-square-foot manufacturing and imaging facility, relocating its operations to Buffalo, New York. There, it will use 3D printing technology ... Read more »

UDI Convenience Kit Guidance Released by FDA ...

by BONEZONE | May 2019 (Legal, Clinical & Regulatory) FDA finalized UDI guidance for convenience kits and provided orthopedic-specific examples as context in the document. FDA finalized guidance seeking to clarify its definition of convenience kits for ... Read more »

UDI Laser Marking Improved with Vision Technology ...

by Faycal Benayad-Cherif | Apr 2019 (Research & Development) ... to apply UDI codes.    Regulatory bodies around the world are implementing Unique Device Identification systems (UDI) for traceability of implants and instruments throughout their entire product lifecycle, ... Read more »

Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI ...

by Julie A. Vetalice | Apr 2018 (Voice of Industry) ... ConnectSx, an eHealth company that addresses inventory management, UDI compliance, just-in-time training/knowledge delivery, and electronic transaction capabilities delivering new efficiency and discipline ... Read more »

UDI: Is Your System Ready for Scale? ...

by Carolyn LaWell | Jan 2018 (Legal, Clinical & Regulatory) UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval. Call it a forever project, program, ... Read more »

ConnectSx Launches UDidentify Mobile App ...

by BONEZONE | Jan 2018 (Supplier News Items) The free app scans and validates HIBCC and GS1 barcodes used for compliance with FDA unique device identification (UDI) ConnectSx, a Mokena, Illinois-based startup providing SaaS solutions that support ... Read more »

MedTech Momentum Launches Video Production Studio ...

by BONEZONE | Dec 2017 (Supplier News Items) The venture covers a wide range of video formats for medical companies to choose from. MedTech Momentum's new video production studio is dedicated to serving medical companies around the globe. Th ... Read more »

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

by John Gagliardi | Dec 2017 (Legal, Clinical & Regulatory) ... were slow to adopt the Medical Device Single Audit Program (MDSAP) in its pilot days, the initiative has gained traction since FDA’s Center for Devices and Radiological Health (CDRH) named it an official ... Read more »

Understanding the Critical Differences Between Supplier Audit and Evaluations ...

by Martin Browning | Dec 2017 (Supply Chain Management) Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gather ... Read more »

UDI Direct Marking Guidance Finalized by FDA ...

by Rob Meyer | Nov 2017 (Legal, Clinical & Regulatory) ... recently finalized guidance on direct marking a medical device with unique device identification (UDI), providing orthopaedic manufacturers with an unsurprising position on marking methods and identical ... Read more »

Grace College and OrthoWorx Update Orthopaedic Graduate Studies Program ...

by BONEZONE | Oct 2017 (Supplier News Items) After six years of successful operation and more than 100 graduates of ORCA, it was time to revise the program. Grace College and OrthoWorx have launched an updated curriculum for their collaborative ... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit ...

by John Gagliardi | May 2017 (Legal, Clinical & Regulatory) ... and the approach of the investigator or the auditor that makes the experience very different.  In the books, the current Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each ... Read more »

How Often Should You Audit Your Suppliers? ...

by Martin Browning | Jan 2017 (Supply Chain Management) EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing insight. EduQuest, a global team of FDA compliance experts, ... Read more »

Making the Most of UDI ...

by Chris Mosby | Aug 2016 (Legal, Clinical & Regulatory) 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 ... Read more »

FDA Releases UDI Education as Deadline Approaches  ...

by BONEZONE | Apr 2016 (Legal, Clinical & Regulatory) 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 ... Read more »

Orchid's Kellen Hills Receives ASQ Quality Auditor Certification ...

by BONEZONE | Jan 2016 (Supplier News Items) ... has completed the requirements to be named an ASQ-Certified Quality Auditor (ASQ CQA). Kellen Hills joined Orchid Design Team in Memphis in October 2013. Prior to joining Orchid, Kellen held various ... Read more »

UDI Update: Trays and Kits ...

by BONEZONE | Jan 2016 (Legal, Clinical & Regulatory) 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 ... Read more »

UDI Ruled a Requirement for EHRs ...

by BONEZONE | Dec 2015 (Legal, Clinical & Regulatory) 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, ... Read more »

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices ...

by BONEZONE | Jul 2015 (Legal, Clinical & Regulatory) 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. Orthopaedic ... Read more »

FDA Launches Searchable UDI Database  ...

by BONEZONE | Jun 2015 (Legal, Clinical & Regulatory) FDA recently announced the launch of AccessGUDID, a website that allows users to search and download information on devices that require identification. FDA has launched the database that links the ... Read more »

The Basics: Understanding the Medical Device Single Audit Program ...

by Robert Packard | Feb 2015 (Legal, Clinical & Regulatory) ... participation. FDA and regulatory counterparts in several countries introduced the Medical Device Single Audit Program (MDSAP) Pilot, an international effort to harmonize the inspection and auditing ... Read more »

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

by Hannah Corcoran | Feb 2015 (Legal, Clinical & Regulatory) ... Unique Device Identification (UDI) implementation and premarket/postmarket controls enforcement. In a Medmarc webinar entitled, “FDA CDRH in 2015: Gazing through the Crystal Ball,” John Avellanet, founder ... Read more »

Unique Device Identification (UDI): Many Questions Remain  ...

by Karen Conway | Dec 2014 (Legal, Clinical & Regulatory) 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 »

FDA Extends UDI Compliance Date for Certain Orthopaedic Implants ...

by BONEZONE | Dec 2014 (Legal, Clinical & Regulatory) A variety of fixation screws, plates and spinal devices will not need to meet UDI labeling requirements until 2016. Effective immediately, FDA’s Center for Devices and Radiological Health (CDRH) is ... Read more »

GHX Successfully Submits Product Data to the FDA Production Global UDI Database (GUDID) Ahead of Deadline ...

by BONEZONE | Sep 2014 (Supplier News Items) One day before FDA's deadline for medical device companies to submit Class III product data to FDA's Production Global UDI Database (GUDID), GHX announced that in August its UDI solution and services practi ... Read more »

FDA Publishes Q&A on UDIs ...

by BONEZONE | Sep 2014 (Legal, Clinical & Regulatory) 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. The deadline for ... Read more »

Turner Medical Reports Zero Findings in FDA Audit ...

by BONEZONE | Jul 2014 (Supplier News Items) Turner Medical is pleased to announce zero findings in its recent FDA audit. Turner Medical, based in Athens, Alabama, is a family-owned contract manufacturer that has a 70,000 square foot facility dedicated ... Read more »

UDI Implementation: What are Your Next Steps? ...

by Jonathan Bretz | Jun 2014 (Legal, Clinical & Regulatory) Creating a playbook or strategic plan is an absolutely necessary step of UDI implementation. The major components of your plan should include these steps. Unique Device Identification (UDI) implementation ... Read more »

GHX Announces UDI Solution ...

by BONEZONE | Jan 2014 (Supplier News Items) GHX will offer an industry solution that enables manufacturers to publish data to FDA’s Global UDI Database (GUDID) through a single connection that can meet a variety of needs, such as synchronizing data ... Read more »

Auditing Process Validation & Developing Protocols ...

by Robert Packard | Jan 2014 (Supply Chain Management) ... here is how to perform a process validation audit and develop a protocol.                                                                                                                    Continue ... Read more »

FDA Finalizes UDI Requirements  ...

by BONEZONE | Sep 2013 (Legal, Clinical & Regulatory) ... implementation period if public health and supply disruption issues arise. Most Class II devices will need to meet the new requirements in three years. Class I devices that are nonexempt from the UDI ... Read more »

Postmarket Studies in Lieu of Clinical Trials ...

by Robert Packard and Dov Gal | Sep 2013 (Legal, Clinical & Regulatory) A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue sooner. Clinical data is required for all submissions ... Read more »

UDI Update: Prepping for the Final Ruling ...

by Karen Conway | Jul 2013 (Legal, Clinical & Regulatory) OEMs should be asking, and answering, these 11 questions in anticipation of FDA’s final ruling on UDI guidelines. With the final rule for the FDA’s proposed unique device identification (UDI) ... Read more »

What if Your ISO Auditor is Wrong? ...

by Robert Packard | Apr 2013 (Legal, Clinical & Regulatory) Auditors are human. The question is: What should you do when they're wrong? Imagine completing your first ISO Certification audit. Your company received no major nonconformities, but the auditor identifie ... Read more »

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

by Karen Conway | Mar 2013 (Legal, Clinical & Regulatory) 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 announcemen ... Read more »

Develop Orthopaedic Implants Faster Through Auditing ...

by Robert Packard | Feb 2013 (Supply Chain Management) Do your auditing techniques actually improve product development? These three techniques—one simple, one advanced and one new—will shorten the cycle. Most auditors pretend to “add value.” Adding value ... Read more »

Medical Metrics Selected as Imaging Core Lab for Multiple FDA Metal-on-Metal Hip Studies  ...

by BONEZONE | Dec 2012 (Supplier News Items) ... FDA surveillance studies of metal-on-metal (MoM) hip implants. MMI will independently evaluate radiographs and MRI to assess long-term outcomes in patients implanted with MoM hips. Over 2,000 subjects ... Read more »

In Vivo Bone Growth Assessment in Preclinical Studies and Clinical Trials ...

by Amit Vasanji, Ph.D. | Aug 2012 (Research & Development) ... osseointegration studies, combined with patient or animal population-based variability in reaction/response to such surrogates, necessitates unrealistically large cohorts for adequate power and ultimate ... Read more »

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

by Sandra Maddock, RN, BSN, CCRA | Mar 2012 (Legal, Clinical & Regulatory) ... Health (CDRH) established two internal committees to review the 510(k) program, including the 510(k) Working Group and the Task Force on Utilization of Science in Regulatory Decision Making. In addition, ... Read more »

The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties ...

by John Gagliardi | Aug 2011 (Research & Development) FDA analysis of factory inspections has shown that manufacturers who do not have an adequate quality audit system usually do not have an adequate quality system. An evaluation of approximately 2,400 manufacturers ... Read more »

Study Finds Additive Manufacturing Success with Nitinol

by Gaurav Lalwani, Ph.D. | Aug 2020 (Research & Development) Carpenter Additive carried out a study to create a systematic framework to optimize additive manufacturing for Nitinol. The study focused on multiple factors, including stringent control of Nitinol chemistry. ... Read more »

3 Questions on 3D Printing

by Patrick McGuire | Aug 2020 (Research & Development) ... . These materials have been proven to be printable with relative ease of production, and studies of their efficacy are available. Additionally, traditional manufacturing of Nitinol is complicated and utilizi ... Read more »

Additive Manufacturing Advancements to Boost Use in Orthopedics

by Kathie Zipp | Aug 2020 (Business Critical) ... with more than 250 additive manufacturing machine and material suppliers, service bureaus and users in various industries, including medical. We asked Dr. Munsch to share insight gleaned from the report ... Read more »

SI Joint Fusion Market Has Rapid Growth Potential

by Mike Evers | Aug 2020 (Business Critical) ... (including SI joint fusions) is $915. SI-BONE wrote in its 2019 annual report, “We believe that some surgeons may continue to view the Medicare and commercial reimbursement amounts as insufficient for ... Read more »

Why Nexxt Spine Prioritized In-House 3D Printing

by Mike Evers | Aug 2020 (Voice of Industry) ... not all created equal. Surgeons are going to move away from PEEK and coated PEEK to 3D-printed titanium; we’ll continue to see that shift as the education grows. As the data comes out, more studies come ... Read more »

OEMs Look to Suppliers for Vendor Managed Inventory Help

by Heather Tunstall | Aug 2020 (Supply Chain Management) ... to hospital. Now, the lack of clarity surrounding the business impact of COVID-19 has forced companies to rethink their strategies, including packaging, warehousing, forecasting and distribution. With ... Read more »

Norman Noble Expands Operations in Ohio

by BONEZONE | Jul 2020 (Supplier News Items) ... contract manufacturing of medical implants. The company specializes in validated micromachining and welding of implants from exotic materials, including Titanium, PEEK and Nitinol, to complex geometries ... Read more »

How to Create a Product Development Roadmap

by Kathie Zipp | Jul 2020 (Research & Development) ... e “trip,” including where you’re going and the steps you need to get there. “Taking a road trip is fun, but the worst thing that can happen is discovering you forgot something important,” he says. “Y ... Read more »

Why You Should Engage Suppliers in DFMEAs

by BONEZONE | Jul 2020 (Research & Development) ... released. Successful design and manufacture of an implant requires that everyone involved, including your contract manufacturer, is familiar with the product and its components. Autocam Medical Account ... Read more »

OrthoDX Creates Prototype for Joint Replacement Implantable Sensor

by Patrick McGuire | Jul 2020 (Research & Development) ...  it to bone. I have been in discussion with colleagues who feel they could develop this within six months, once they’re given the green light. The same goes for animal studies. Of course, we need to discus ... Read more »

Orteq Promotes Joint Preservation with Meniscus Implant

by Kathie Zipp | Jul 2020 (Research & Development) ... when assessing a patient’s knee joint, considering many factors, including alignment, stability, meniscus and cartilage. As soon as you remove even part of the meniscus, the patient begins heading down ... Read more »

Elos Medtech Shares Planned Succession Changes in Memphis

by BONEZONE | Jul 2020 (Supplier News Items) Tim Turner will succeed Jodie Gilmore in leading Elos Medtech in Memphis, Tennessee. Mr. Turner has been with the company for more than 16 years and served in increasing leadership roles, including production ... Read more »

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

by Julie A. Vetalice | Jul 2020 (Legal, Clinical & Regulatory)  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. FDA has made multiple ... Read more »

Zimmer Biomet’s mymobility Shows Data’s Promise in Orthopedics

by Carolyn LaWell | Jul 2020 (Business Critical) ... 0 enrollees, the clinical study is expected to be one of the largest evidence-gathering clinical studies in orthopedic history. Data from the study will be available later this year. Carolyn LaWe ... Read more »

FDA 510(k) Recap: Spine Company Clearances

by Julie A. Vetalice | Jul 2020 (Legal, Clinical & Regulatory) ... date, since January. Of note, the majority of these clearances were granted within a short timeframe, including three within the month of submission (Life Spine, Nexxt Spine, SeaSpine). CarboFix Orthopedics ... Read more »

OsteoFab PEKK: Desirable Material Properties and 3D Printing Combine to Enhance Orthopedic Solutions

by Andrus Maandi | Jul 2020 (Research & Development) Numerous studies on material and implant structure have detailed the benefits of OsteoFab PEKK – a formulation of polyetherketoneketone – that is 3D-printed for orthopedic applications. Sponsored Conventionally, ... Read more »

Aran Biomedical Names Todd Blair as VP Sales & Business Development, U.S.

by BONEZONE | Jul 2020 (Supplier News Items) ... re than 20 years of experience in sales and business development within the life sciences contract manufacturing industry, with a focus on implantable materials and technologies, including bio-textiles, niti ... Read more »

N2 Biomedical Awarded Patents for Infection Prevention, Bone Integration

by BONEZONE | Jul 2020 (Supplier News Items) ...  proprietary coating is designed to enhance bone integration by engineering multiple levels of texture on a medical device surface, including macro, micro and meso or sub-nanoscale levels. “This low-temperatur ... Read more »

FDA Repeats Call for Advanced Manufacturing Efforts

by Carolyn LaWell | Jul 2020 (Legal, Clinical & Regulatory) ... , the agency has initiated multiple programs including Voluntary Improvement Program (VIP) and makeCAPACool. Overall, FDA seeks new, collaborative and data-driven regulatory models. Advanced Manufacturi ... Read more »

New 3D-Printed Liquid Crystal Elastomer Developed for Spine

by Heather Tunstall | Jul 2020 (Research & Development) ... set of studies that utilize LCEs for both spinal fusion techniques and potential disc replacement. The Concept Traditionally it has been difficult to develop a material that can expand or contract ... Read more »

3T Additive Manufacturing Dramatically Reduces Part Setup Time

by BONEZONE | Jul 2020 (Supplier News Items) ... of industry sectors, including companies that produce orthopedic implants and instruments, primarily using Laser Beam Powder Bed Fusion. The company has experienced strong growth in recent years, and while ... Read more »

Resonetics Completes Costa Rica Expansion

by BONEZONE | Jun 2020 (Supplier News Items) ...  for export and for the local medical device industry. Resonetics notes that presently, eight of the top 30 life sciences companies worldwide have facilities in Costa Rica, including Medtronic and Smith+Nephew ... Read more »

MedTorque Introduces the TRI-GEAR Eclipse Ratchet

by BONEZONE | Jun 2020 (Supplier News Items) ... as legacy TRI-GEAR ratchet drivers Available with the standard MedTorque customization options, including the choice of many standard quick couplings or a custom, integrated driveshaft and color customization ... Read more »

Orthopedics This Week Partners with MedTech Momentum and Synthes'3D to Launch Next Gen 3D Virtual Convention Solution

by BONEZONE | Jun 2020 (Supplier News Items) ... meeting organizers extend their reach and audience Help physician societies increase and diversify their revenue stream Provide a next generation interactive, collaborative networking tool for ... Read more »

Smith+Nephew Launches INTELLIO Connected Tower for Sports Medicine

by Julie A. Vetalice | Jun 2020 (Research & Development) ... combines numerous elements of Smith+Nephew's offerings, including: The LENS™ Connected Tower app which remotely manages patient work lists, captures images and videos, and controls COBLATION™ and resectio ... Read more »

Spinal Elements Introduces the MIS Ultra Platform of Products and Procedures

by Julie A. Vetalice | Jun 2020 (Research & Development) ... organically-developed solutions,” said Jason Blain, President and CEO. “We expect that our most recently released products in this arena, including Katana, will drive company growth, as will the next several ... Read more »

Orthopedic Outlook: COVID-19’s Impact on Industry Growth and Trends

by BONEZONE | Jun 2020 (Business Critical) ... es and robotics Stringent regulations worldwide with UDI and the EU’s Medical Device Regulation Upswing of gain-sharing and surgeons’ co-management of orthopedic “business” We expect these tre ... Read more »

DiFusion Brings First Immuno-stealth Polymer to Orthopedic Market

by Kathie Zipp | Jun 2020 (Research & Development) ... animal studies, we achieved a goal no large company would dare to even undertake,” said Derrick Johns, DiFusion’s Founder and CEO. “We are the only ones out there with a new cleared material. Everyone ... Read more »

Additive Manufacturing Success Relies on Titanium Powder Quality

by Gaurav Lalwani, Ph.D. | Jun 2020 (Business Critical) ... inert gas, producing highly spherical powder particles. The EIGA method has multiple advantages over the PA process, including the use of bar feedstock as opposed to wire, allowing for greater supply chain ... Read more »

Glebar Acquires Everite Machine Products

by BONEZONE | Jun 2020 (Supplier News Items) ... Grinding (ECG) technology. For over 70 years, Everite has specialized in ECG machines for global customers in industries including medical and aerospace markets. Everite offers Burr-Free Cutoff, Surface ... Read more »

J-Pac Medical Announces New EtO Sterilization Services

by BONEZONE | Jun 2020 (Supplier News Items) New Ethylene Oxide services include worst case EO exposure cycles to support packaging validation and material compatibility studies.    J-Pac Medical commenced Ethylene Oxide (EtO) sterilization services. ... Read more »

Traditional Metals Meet Mainstream Adoption in Orthopedics

by Kathie Zipp | May 2020 (Business Critical) ... device company Bioretec focuses solely on bioabsorbable and bioresorbable implants for pediatric and adult orthopedics, including pins, nails and screws. Chief Technology Officer Kimmo Lähteenkorva said  ... Read more »

What Should an Industry 4.0 Workforce Look Like in Orthopedics?

by Heather Tunstall | May 2020 (Business Critical) The advancement of automation on the manufacturing floor requires orthopedic companies to face a shift in talent acquisition and expectations, including a higher level of technical acumen needed to compete ... Read more »

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

by BONEZONE | May 2020 (Legal, Clinical & Regulatory) ... Society of Quality (ASQ) as a Certified Quality Auditor (CQA), and by Exemplar Global (RABQSA) as an ISO 13485:2016 Lead Auditor and an EU MDR Auditor.     ... Read more »

OPM Announces Proprietary Technology for Applying Nanoscale PEKK Coating to Orthopedic Devices

by BONEZONE | May 2020 (Supplier News Items) ... during production processes. When applied, it produces an ultra-thin film designed to provide the full range of the biological features of poly-ether-ketone-ketone – including osseoconductivity, antibacterial ... Read more »

OEMs and Suppliers Share Best Practices in Collaborative Forecasting

by Heather Tunstall | May 2020 (Supply Chain Management) ... for device companies and contract manufacturers. Partners within the orthopedic supply chain share a variety of challenges, including forecast visibility, forecast stability, relevant capacity plans, the ... Read more »

How Will FDA's CDRH Reorganization Impact Me?

by BONEZONE | May 2020 (Legal, Clinical & Regulatory) ... Senior Partner in the MB&A Consulting firm specializing in FDA, ISO and MDSAP audit management and response, contract Due Diligence Inspections and US/Asia supplier relationship management. Her GXP experience ... Read more »

What Does the Next Generation of Total Ankles Need?

by Kathie Zipp | May 2020 (Research & Development) ... for new systems. More total ankles are in development, including Articulus Bio’s Ultra High Molecular Weight Polyethylene implant. Alan Davis, M.D., a foot and ankle surgeon at Cleveland Clinic, was ... Read more »

Embody Raises Funds for Soft Tissue Repair Technology

by Julie A. Vetalice | May 2020 (Research & Development) Funds will support commercial launch and postmarket clinical studies of the Tapestry system to treat serious tendon and ligament injuries.    Embody closed a $9.3 million Series A funding round. Proceeds ... Read more »

M&A Update: Stryker and Wright Medical, RTI Surgical, ATEC

by Mike Evers | May 2020 (Business Critical) ... activity, including Stryker’s planned acquisition of Wright Medical, RTI Surgical’s sale of its OEM business and ATEC’s agreement to purchase EOS imaging. However, the COVID-19 pandemic created substantial ... Read more »

Greenlight Guru and Emergo by UL Bundle OEM Offerings to Bring Devices to Market Faster

by BONEZONE | Apr 2020 (Supplier News Items) ... System (QMS) consulting services and cloud-based Regulatory Affairs Management Suite (RAMS). Greenlight Guru’s MDQMS supports closed-loop quality traceability for real-time audit readiness, while accelerating ... Read more »

Integrated Endoscopy Solves Arthroscope Design Challenges with NUVIS

by Heather Tunstall | Apr 2020 (Research & Development) ... equipment,” Cripe said. “We’re not trying to displace all of the reusable arthroscopes today; we’re going in as the backup to your existing equipment, including arthroscopes, because downtime and breakage ... Read more »

COVID-19 Heightens Focus on the Cost of Orthopedic Care

by Carolyn LaWell | Apr 2020 (Business Critical) In this video interview with Peter Althausen, M.D., we discuss how COVID-19 will change care delivery, including shifting procedures to outpatient settings and placing scrutiny on implant utilization. ... Read more »

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

by Julie A. Vetalice | Apr 2020 (Legal, Clinical & Regulatory) ... Option Ceramic Heads relating to a manufacturing site transfer for the subject devices, a change of sterilization sub-contractor, labeling changes (including changes to IFU and labels) and packaging changes ... Read more »

How to Implement a Solid Approach to Materials Intelligence

by Ben Conlon and Marc Horner | Apr 2020 (Research & Development) ...  DESIGN PHASE A crucial place to make intelligent material decisions is in the earliest phases of device design. Indeed, studies find that 50% of the recalls are a result of design decisions from this ... Read more »

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

by Julie A. Vetalice | Apr 2020 (Legal, Clinical & Regulatory) ... ty levels, improve functional outcomes and increase patient satisfaction scores with high statistical significance. Studies indicate that 98% of patients whose knees were balanced using VERASENSE repor ... Read more »

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

by Julie A. Vetalice | Apr 2020 (Legal, Clinical & Regulatory) ... ed in the U.S. during concurrent Investigational Device Exemption studies to obtain FDA approval for one- and two-level use. The first two-level implantation in the U.S. took place in 2002 as a part of  ... Read more »

Amplify Additive Receives ISO 13485 Certification

by BONEZONE | Apr 2020 (Supplier News Items) ... for Contract 3D Metal Printing/additive manufacturing of orthopedic implant components. ISO certification demonstrates a quality management system throughout the company. The Stage 2 Audit for ISO certification ... Read more »

Global Innovative Products Launches EDM Wire Online Store

by BONEZONE | Apr 2020 (Supplier News Items) Company to sell full line of EDM wires, including laser welding wire for the medical device market.    Global Innovative Products (GIP) launched an EDM wire online store with products to serve all ... Read more »

United Performance Metals Achieves ISO 13485:2016 Approval for Connecticut Branch

by BONEZONE | Apr 2020 (Supplier News Items) The company's South Windsor, Connecticut branch now holds three separate Quality Management Registration Systems, including ISO 9001:2015 and ISO 13485:2016.    United Performance Metals (UPM) successfull ... Read more »

6 Best Practices for Successful Product Commercialization

by Heather Tunstall | Apr 2020 (Business Critical) ...  concerns and the potential need for post-approval studies. Next, conduct regulatory intelligence on possible precedents. You can often find analogies in other products, even in areas outside of orthopedics ... Read more »

Beamalloy Technologies Granted Patent for Ion Beam Enhanced Deposition Coating Process

by BONEZONE | Apr 2020 (Supplier News Items) ... allows deposition of hard coatings such as Titanium Nitride directly on the surfaces of components made from materials including most metals, ceramics and glass. Dr. Arnold Deutchman, Chairman and Director ... Read more »

Solvay Partners with ResMart for Resin Distribution

by BONEZONE | Mar 2020 (Supplier News Items) ...  has been distributing several of Solvay’s specialty polymers for healthcare applications in North America for the last five years, including Radel® polyphenylsulfone, Veradel® HC polyethersulfone and Udel ... Read more »

Orthopedic Companies Provide Help in Challenging Times

by Julie A. Vetalice | Mar 2020 (Business Critical) ... and market pricing solution built for hospital supply chain and value analysis professionals. Lookup by Curvo pulls data from FDA UDI, Device Recalls, MAUDE reports and Orthopedic Network News classifications ... Read more »

6 Orthopedic Trends You Can’t Ignore

by Carolyn LaWell | Mar 2020 (Voice of Industry) ... in and around FDA, things will probably shut down.” COVID-19’s most significant impact on the regulatory environment has been on clinical studies, Stiegman said. Companies involved in Investigational ... Read more »

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

by Julie A. Vetalice | Mar 2020 (Legal, Clinical & Regulatory) 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 Syste ... Read more »

3D LifePrints Gains Funding to Support Global Expansion

by BONEZONE | Mar 2020 (Supplier News Items) ...  from embedded 3D printing facilities/hubs at three U.K. hospitals. It seeks to expand to 50 hubs by 2024, including the U.S. and throughout Europe. Paul Fotheringham, Founder and CTO, said, “We are extremel ... Read more »

AMETEK Completes Sale of Reading Alloys to Kymera International

by BONEZONE | Mar 2020 (Supplier News Items) ... y $160 million and was sold for $250 million in an all-cash transaction. Kymera is focused on non-ferrous powders, granules and pastes including aluminum, copper, tin and their alloys. The company sel ... Read more »

COVID-19: Orthopedic Procedure Deferrals Will Lead to Revenue Declines

by Mike Evers | Mar 2020 (Business Critical) ... and supplies. Non-urgent spine and orthopedic surgeries, including hip and knee replacement and elective spine surgery, were classified as Tier 2a and should consider being postponed. Before government ... Read more »