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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 »

Muvr Labs Brings Wearable Technology to Joint Replacement Recovery

by Heather Tunstall | Jan 2020 (Research & Development) ... recovery for orthopedic patients requires a regimen of physical therapy to improve strength or range of motion. Often, however, a number of obstacles prevent full recovery, including a patient’s other ... Read more »

Year in Review: Orthopedic Companies with First U.S. Products

by Julie A. Vetalice | Jan 2020 (Business Critical) ... trauma, sports medicine, CMF/dental, veterinary) Process uses ultrasonic energy to liquefy pre-defined polymeric components of the Elaris Pin, extruding them through the screw’s fenestrations and forming ... Read more »

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

by Julie A. Vetalice | Jan 2020 (Legal, Clinical & Regulatory) ... bones in adult patients, including the clavicle, pelvis, scapula, long and small bones (metacarpals, metatarsals, phalanges) About the company: Founded 1999 Manufactures spine, trauma, sports medicine ... Read more »

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

by Heather Tunstall | Jan 2020 (Legal, Clinical & Regulatory) ... The 2019 version clarifies previously used terminology, expands some requirements, including for postmarket surveillance, and creates synergies with global regulations. Until this most recent update, ... Read more »

RTI Surgical to Become Pure-Play Spine Company with Sale of OEM Business

by Julie A. Vetalice | Jan 2020 (Business Critical) ... across over 400 investments made in the last 50 years. RTI's OEM segment addressed specialty and niche surgical hardware and implants developed and manufactured for customers including Medtronic, Stryke ... Read more »

ASTM Launches Personnel Certificate in Additive Manufacturing

by Julie A. Vetalice | Jan 2020 (Research & Development) ...  related to best practices, including standardized methodologies. The course is open to anyone with interest in additive manufacturing/3D printing Specific modules include: Terminology AM proces ... Read more »

AMETEK to Sell Reading Alloys to Kymera International

by BONEZONE | Jan 2020 (Supplier News Items) ... tes including aluminum, copper, tin and their alloys, which it sells to a range of end markets, including additive manufacturing applications.  ... Read more »

Conventus Orthopaedics Acquires Intramedullary Technology from IntraFuse

by Julie A. Vetalice | Jan 2020 (Business Critical) ... proximal humerus.    Conventus Orthopaedics acquired all assets of IntraFuse, including proprietary intramedullary implants for the minimally invasive repair of fibula and other fractures. The move ... Read more »

DePuy Synthes, Zebra Medical to Partner on AI in Orthopedics

by Julie A. Vetalice | Jan 2020 (Research & Development) ...  and improve orthopaedic procedures and outcomes in areas including the knee, hip, shoulder, trauma and spine care,” said Eyal Gura, Co-Founder and CEO of Zebra Medical Vision. “We share a common visio ... Read more »

Stratasys Appoints Yoav Zeif as New CEO

by BONEZONE | Jan 2020 (Supplier News Items) ...  additive manufacturing and 3D printers to create prototypes, manufacturing tools and production parts for a wide range of industries, including healthcare. In 4Q19, the company introduced the J750 Digita ... Read more »

J-Pac Medical Announces Director of Program Management

by BONEZONE | Jan 2020 (Supplier News Items) ... responsibility for all new customer project coordination, including all customer-facing projects. This new role manages the new product realization process to help a new customer program to reach commercialization. ... Read more »

6 Orthobiologic Companies Move Clinical Trials Forward

by BONEZONE | Dec 2019 (Research & Development) ...  goal of the double-blinded, multi-center trial is to demonstrate the effectiveness of this point-of-care cell therapy. The trial will enroll 246 patients at up to 15 U.S. sites, including a group of patient ... Read more »

Update on Precision Coating Strategic Activities

by BONEZONE | Dec 2019 (Supplier News Items) ... was audited and found to be fully in compliance with the ISO 13485:2016 standard. The company was certified by the Notified Body, SGS United Kingdom Limited for the application of anodic coatings, including ... Read more »

Starrett Names Metrology Systems VP

by BONEZONE | Dec 2019 (Supplier News Items) ... newly-created role, Mr. Allen will oversee the strategy, growth and profitability of advanced metrology systems including Starrett Bytewise, Tru-Stone Technologies, Starrett-Kinemetric Systems, Starrett ... Read more »

Executive Interview: Carmell Therapeutics on its Controlled Degradable Biologic

by Heather Tunstall | Dec 2019 (Research & Development) ... through the BLA [Biologic License Application] approval process. There’s a lot more rigor and consistency, and we’ll have efficacy data from two Level 1 clinical studies.” The Regulatory Approach Carmell ... Read more »

Strategic Initiatives: CrossRoads Extremity Builds Portfolio, Mathys and BREHM to Co-Market Products

by Julie A. Vetalice | Dec 2019 (Research & Development) ... including devices for sports medicine and trauma applications. The add-on acquisition furthers CrossRoads’ strategy to grow its presence in the orthopedic extremities sector. The transaction includes: ... Read more »

4 New Technologies in Spine, Joint Replacement, Trauma, Sports Medicine

by Julie A. Vetalice | Dec 2019 (Research & Development) ... heads (including a BIOLOX®delta ceramic head made by CeramTec), acetabular shells, acetabular liners, acetabular bone screws, etc. The Blade is designed for the Direct Anterior Approach and features ... Read more »

Orthopedic Success Will Require Digitalization of Supply Chains and Products

by Carolyn LaWell | Dec 2019 (Voice of Industry) ... other bright minds are in the audience. Put them together for two days, and magic happens. DOCSF at its core is a networking event where we level-set the audience on a handful of topics and then let the ... Read more »

NN, Inc. Names Chris Qualters as Executive Vice President, Life Sciences

by BONEZONE | Dec 2019 (Supplier News Items) ...  pursue new endeavors. Mr. Qualters brings nearly 30 years of experience leading and driving strategy for engineered products businesses, including orthopedics, with expertise in front-line engineerin ... Read more »

TÜV SÜD and ASTM International Launch Partnership in Additive Manufacturing

by BONEZONE | Dec 2019 (Supplier News Items) ... pports knowledge-sharing and the growing use of AM/3D printing across a variety of industry sectors, including healthcare. The partnership will include joint development of new educational, advisory, q ... Read more »

Sandvik and Renishaw to Qualify New Additive Manufacturing Materials

by BONEZONE | Dec 2019 (Supplier News Items) The collaboration encompasses a broad range of metal powders, including new alloy compositions that are optimized for laser powder-bed fusion.    Renishaw is collaborating with Sandvik Additive Manufacturing ... Read more »

MCRA Selected by THINK Surgical to Support FDA Clearance for Surgical Robot

by BONEZONE | Dec 2019 (Supplier News Items) ... 0% patient retention rate, improving the reliability of the study's statistical outcomes Conducting site audits and preparing the sponsor and sites for the five Bioresearch Monitoring Program inspect ... Read more »

New Venture Capital Firm Vensana has Orthopedic Roots

by Kathie Zipp | Dec 2019 (Supplier News Items) ...  starting Vensana, we aim to be a great partner to the whole medtech ecosystem including startup companies, as well as their investors and corporates.” Nielsen also thinks that the startup nature of Vensan ... Read more »

Lack of Clinical Evidence Leaves Questions about Orthobiologic Development and Promotion

by Scott Burder, M.D., Ph.D. | Dec 2019 (Legal, Clinical & Regulatory) ... would have eclipsed the overall market by several percentage points. Notwithstanding this ~5% year-over-year decline in viscosupplementation, a handful of products within this category (including injectable ... Read more »

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

by Julie A. Vetalice | Dec 2019 (Legal, Clinical & Regulatory) ... (total hip arthroplasty) with or without autograft or allograft, CPT code 27130 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or ... Read more »

3 FDA Actions to Reduce Ethylene Oxide Sterilization

by Heather Tunstall | Dec 2019 (Legal, Clinical & Regulatory) ... it selected 12 applicants, including orthopedic device manufacturers and well-known sterilization companies, to move forward in its innovation challenge. FDA initiated the innovation challenges earlier ... Read more »

Evonik Signs Global Agreement, Expands RESOMER Portfolio

by BONEZONE | Nov 2019 (Supplier News Items) ... devices, Evonik continues to strengthen its position as a preferred global partner for medical device companies. Together with other recently launched biomaterial innovations including PLA-PEG copolymers, ... Read more »

nTopology Releases New Version of Computational-Modeling Software

by BONEZONE | Nov 2019 (Supplier News Items) ...  uses, including ANSYS, Abaqus and Nastran. Topology Optimization Toolkit Discover new and innovative designs early in the product development cycle. Apply multiple loading conditions and optimiz ... Read more »

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

by Julie A. Vetalice | Nov 2019 (Legal, Clinical & Regulatory) ...  Joining others with dual mobility systems, including Aston Medical, Corin, LimaCorporate, Serf, Smith+Nephew, Stryker, Waldemar Link and Zimmer Biomet Smith+Nephew | OR3O Dual Mobility System, K191002 ... Read more »

Orthopedic Industry Investors Talk Funding Trends

by Heather Tunstall | Nov 2019 (Business Critical) ... in the future. Viscogliosi: We will continue along the pathway of focusing our attention on carve-outs that relate to a set of 15 themes that we’ve decided to invest our family capital around, including ... Read more »

Design for Manufacturing: An Engineer’s Guide to Machine Tools

by Heather Tunstall | Nov 2019 (Research & Development) ... are called “flutes,” and they often spiral down the surface of a tool bit. The more flutes, the smoother the finish of the resulting hole. There are five main types of tool bits, including a centering ... Read more »

New Trademark Laws Stress Quality and Integrity of Registration

by John W. Boger, Esq. | Nov 2019 (Legal, Clinical & Regulatory) 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 ... Read more »

Unitedcoatings Group Launches Lincotek Additive

by BONEZONE | Nov 2019 (Supplier News Items) ... to provide a complete additive service offering for customers' supply chains. Lincotek Additive will allow an improved focus on the group's additive capabilities, including expertise in research, design ... Read more »

DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial

by Julie A. Vetalice | Nov 2019 (Legal, Clinical & Regulatory) ... device made from ZFUZE biomaterial. ZFUZE is designed to present an alternative to the limitations of PEEK and titanium for load-bearing implants. Studies have shown that ZFUZE material elicits a pro-reparative ... Read more »

Total Joint Orthopedics and CeramTec Launch Novel Femoral Head

by Julie A. Vetalice | Nov 2019 (Supplier News Items) ...  Hip, which is intended for hip replacement to treat a range of conditions, including non-inflammatory degenerative joint disease, rheumatoid arthritis, hip dysplasia and revision procedures. George N ... Read more »

VELO3D Announces Assure Quality Assurance and Control System for 3D Metal Printing

by BONEZONE | Nov 2019 (Supplier News Items) ...  like acetabular cups. Stratasys Direct provides 3D printing and advanced manufacturing services using a range of additive and conventional technologies, in materials including titanium and cobalt chrome ... Read more »

Pristine Surgical Enters Sports Med Market with Single-Use Surgical Imaging System

by Heather Tunstall | Nov 2019 (Research & Development) ...  add to the Pristine Connect platform, including patient engagement tools, pre- and post-op communications and training components. Access to the platform is ubiquitous through an app interface and basi ... Read more »

Stryker Boosts Extremities Portfolio with Wright Medical Acquisition

by Mike Evers | Nov 2019 (Business Critical) ...  portfolios for Stryker and Wright Medical will also lead to dis-synergies, including potential anti-trust issues in total ankle replacement products. Leadership repeatedly stated that it is too early t ... Read more »

4 Key Elements of Design Controls

by Heather Tunstall | Nov 2019 (Research & Development) ... manufacturer establish and maintain procedures to make certain that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user ... Read more »

FDA Announces Advisory Panel, Releases Report on Metal Implants

by Heather Tunstall | Oct 2019 (Legal, Clinical & Regulatory) ... design appropriate pre-market studies and develop appropriate acceptance criteria. Regarding testing, there are only a few validated tests that assess adverse responses to metal implants and there is no ... Read more »

3 Stem Cell Product Updates: Knee OA Clinical Trials, Degenerative Disc Treatment Launch

by Julie A. Vetalice | Oct 2019 (Research & Development) ... the U.S., with additional sites to come in 4Q19 and early 2020. Future trials are planned for other orthopedic applications, including hips and shoulders. PSC is working within FDA’s regulations to provide ... Read more »

Unitedcoatings Begins Rebrand to Lincotek

by BONEZONE | Oct 2019 (Supplier News Items) ... to present ourselves under one coherent brand while leveraging the goodwill of our current brands including Turbocoating, Artec, Eurocoating, Surface Dynamics, Anteco, NanoSurfaces, Eurocoating Wuxi and, ... Read more »

Parx Plastics' Antibacterial Polymer Gains EU Patent

by BONEZONE | Oct 2019 (Supplier News Items) ...  in the material. In vivo studies have shown that Parx technologies effectively prevent surface biofilm adhesion. Parx Plastics seeks to partner with a knowledgeable player for co-development of its technolog ... Read more »

GE Additive, Oerlikon Joining Additive Manufacturing Cluster in Bavaria

by BONEZONE | Oct 2019 (Supplier News Items) ... The Additive Manufacturing Institute to focus on interdisciplinary research in raw material powders, optimized AM production and end-to-end process integration, including automation and digitalization, ... Read more »

Contract Lab Complete Laboratory Solutions Adding 100 New Jobs in Ireland

by BONEZONE | Oct 2019 (Supplier News Items) ... premarket studies, cleanroom environmental monitoring and cleaning validation. They also provide sampling, testing and fully trained analysts on contract. CLS laboratories are accredited and approved by ... Read more »

Stratasys Introduces Digital Anatomy 3D Printer

by BONEZONE | Oct 2019 (Supplier News Items) ... products to market by performing design verification, validation, usability studies and failure analysis with these new models.” Stratasys also introduced BoneMatrix™ material specfically designed for ... Read more »

NASS Review: Spinal Robotics, Enabling Technologies, 3D Printing and Biologics

by Mike Evers | Oct 2019 (Research & Development) ...  Many of the executives we spoke to, including Camber Spine, NuVasive, SeaSpine and Spinal Elements, agreed that spine market growth would remain in the low single-digits, and gave figures in the range ... Read more »

Stryker, SeaSpine and Innovasis Ink New Licensing Deals

by Julie A. Vetalice | Oct 2019 (Research & Development) ...  and $11 million upon first FDA 510(k) clearance. The companies also entered into a long-term distribution agreement to manufacture PSI for Stryker, including for the Triathlon Total Knee System. Th ... Read more »

Millstone Medical Outsourcing Expands Headquarters

by BONEZONE | Oct 2019 (Supplier News Items) ... River, Massachusetts. This headquarter campus will hold 124,367 square feet of production space, including its existing 15,000 square feet of class 10,000/ISO 7-rated cleanroom space for medical device ... Read more »

Investing in Delivery Model Disruption

by BONEZONE | Oct 2019 (Supply Chain Management) ...  which data will be captured in more meaningful ways and true, actionable insights will emerge, including in the key area of inventory management. “We need to evolve to a healthcare environment wher ... Read more »

Jade Precision Medical Components Acquired by ARCH Global Precision

by BONEZONE | Oct 2019 (Supplier News Items) ... (AMS) division with facilities in Indiana, Minnesota, New Hampshire, New Jersey and now, Pennsylvania. JPMC specializes in spinal and extremity implants including cannulated polyaxial pedicle screws, ... Read more »

Inventory Management Requires New Tracking Technology and Old-Fashioned Communication

by Heather Tunstall | Oct 2019 (Supply Chain Management) ... platform systems as the need for more robust lot tracking is becoming more necessary than legacy spreadsheets and access tables.” THE EVOLUTION OF TRACKING AND AUDITING Orthopedic device companies have ... Read more »

6 Companies Expand Robotic, Imaging, Navigation Tools via 2019 M&A

by Carolyn LaWell | Oct 2019 (Business Critical) ... like larger robotic systems, the lightweight lower-cost Medineering arm mounts to the side rails of the operating table, making the vendor-neutral platform more accessible for customers, including hosp ... Read more »

How Do EDM and Cutting Tools Work?

by Deborah Munro | Oct 2019 (Research & Development) ... installment on how machine tools work, we’ll consider alternative ways of cutting metal parts, including electric discharge machining (EDM), laser cutters and plasma cutters. These represent the slowest ... Read more »

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

by Julie A. Vetalice | Oct 2019 (Legal, Clinical & Regulatory) 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.    We have identifie ... Read more »

Grover Precision Launches Seamless Tubing

by BONEZONE | Sep 2019 (Supplier News Items) ...  on Swiss machines.  This seamless precision "turn-key tubing" requires no gundrilling and is offered in a variety of materials, including Ti-6AL-4V, 316LVM, 455/465, 17-4PH, Nitinol, MP35N, L605 and other ... Read more »

PrinterPrezz and Osseus to Develop 3D-Printed Spine Implants

by BONEZONE | Sep 2019 (Supplier News Items) ... The two partnered in 2018 to develop Aries products, including ALIF, cervical and expandable lumbar fusion cages. New devices will be submitted to FDA in late 2019. The new designs will leverage the ... Read more »

Sports Medicine Product Updates: CoNextions Medical and Fuse Medical

by Julie A. Vetalice | Sep 2019 (Research & Development) ... two up-and-comers to share. These small startups are increasingly appearing in the news, including recent announcements in mid-September. CoNextions Medical completed enrollment in the clinical trial ... Read more »

Trauma: A Regulatory and Product Launch Recap

by Julie A. Vetalice | Sep 2019 (Research & Development) ... across orthopaedics, including distal extremities, trauma, sports medicine, reconstruction, pediatrics and spine in the form of pins, screws and plates. PRODUCT LAUNCHES Biedermann Motech introduced ... Read more »