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Search Keyword: UDI


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

by Julie 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 »

Fort Wayne Metals to Open New R&D Space

by BONEZONE | Jan 2019 (Supplier News Items) ... in Ireland. The company’s wire materials are found in orthopaedic products including fracture fixation, spinal devices, bone screws, cerclage cables, bone pins, nails, guide/spinal/reamer rods and suture ... Read more »

Skills Gap Hampers Manufacturing Growth, Says Tooling U-SME Report

by Rob Meyer | Jan 2019 (Business Critical) ... best practices for strengthening your team. The manufacturing skills gap continues to hinder many industries—including orthopaedics—and represents a significant impediment to manufacturing growth and ... Read more »

NuVasive Announces New Organizational Structure, Streamlined Leadership Team

by Rob Meyer | Jan 2019 (Business Critical) ...  Business and Quality Systems functions, including GRI, Regulatory Affairs/Quality Affairs, Information Technology and Environmental Health & Safety. Lucas Vitale is named Chief Human Resources Officer ... Read more »

Medtronic Completes US $1.7 BB Acquisition of Mazor Robotics

by Julie A. Vetalice & Rob Meyer | Jan 2019 (Business Critical) ... indicates Medtronic’s belief in the future of guided spinal procedures. Many of its peers have technologies that could be or are being developed for use in the spine, including Johnson & Johnson’s Orthotaxy, ... Read more »

Awake Spinal Fusion Surgeon Urges Industry to Consider Patient Experience

by Carolyn LaWell | Jan 2019 (Voice of Industry) ... under general anesthesia. He plans to publish a second study focused on cost savings for awake lumbar fusion. He believes that cost savings will be higher—around 20%—even excluding length of stay. Dr. ... Read more »

Meddux Development Expanding into New Facility

by BONEZONE | Jan 2019 (Supplier News Items) The engineering design and development firm specializes in a variety of products, including minimally invasive surgical devices for use in interventional spine procedures. Meddux Development, an engineering ... Read more »

Smith & Nephew Acquiring Ceterix, Meniscal Repair Technology

by BONEZONE | Dec 2018 (Business Critical) ... technology allows arthroscopic stitch placement in tight joint compartments to repair complex meniscal tears in knees, hips and shoulders. It treats a broad range of tear types, including horizontal, radial, ... Read more »

Year in Review: Orthopaedic Companies New on Our Radar in 2018

by Julie Vetalice | Dec 2018 (Business Critical) ... implants to improve osseointegration. Preclinical studies in rabbits yielded robust evidence for efficacy and safety. Has submitted a composition of matter patent application in various PCT countries. ... Read more »

In2Bones: 4Q18 Product Launches Focus on Fracture Repair, Foot Deformities

by Julie A. Vetalice & Rob Meyer | Dec 2018 (Business Critical) ... orthobiologics space with products including bone putties and bioactive glass bone graft substitutes. *Images courtesy of In2Bones Julie A. Vetalice, Editorial Assistant and Rob Meyer, Senior ... Read more »

Foster Named Distributor for Two Solvay Polymers

by BONEZONE | Dec 2018 (Supplier News Items) ... custom compounding of these polymers, including custom colors, for specific application requirements. Foster is currently a distributor in the North American healthcare market for Solvay’s Radel polyphenylsulfone, ... Read more »

SLM Solutions Names Aaron LaLonde Director of Applications Engineering

by BONEZONE | Dec 2018 (Supplier News Items) ... an excellent return on their machine investments.” Mr. LaLonde will support customer applications, including those in the orthopaedic industry. In his role, he will also work with customers to answer ... Read more »

DePuy Synthes: A Look at PUREVUE and 2018 Product Launches

by Julie A. Vetalice & Rob Meyer | Dec 2018 (Business Critical) ... at right) completes its capital equipment lineup for arthroscopic soft tissue procedures, including rotator cuff repair, subacromial decompression, shoulder instability, ACL/PCL repair and more. PUREVUE ... Read more »

Cobalt Chrome Additive Total Knee Successfully Tested by Italian Startup

by Julie A. Vetalice & Rob Meyer | Dec 2018 (Business Critical) ... al knee replacement; and Sensoria Health, a provider of artificial intelligence solutions for healthcare including senors for post-op rehab.  Rejoint leadership boasts several decades of experience in  ... Read more »

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

by John Gagliardi | Dec 2018 (Legal, Clinical & Regulatory) ... y process thus freeing the CDRH team to spend more time on what matters most to patients and staff. An example is adoption of the Medical Device Single Audit Program, which allows a single regulatory aud ... Read more »

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

by Martin Browning | Dec 2018 (Legal, Clinical & Regulatory) ...  the e-sigs you want to accept based on your intended use. Companies need a validation protocol (a plan), assessments based on that protocol, audits of the vendor targeting your intended use, assessmen ... Read more »

FDA Takes Several Steps to Strengthen Medical Device Cybersecurity Program

by BONEZONE | Dec 2018 (Legal, Clinical & Regulatory) In order to stay current with the evolving technological landscape and increased insight into cyber threats, FDA recently addressed cybersecurity, including updating previous guidance, a new cybersecurity ... Read more »

Companies Look to Materials to Provide Innovation, Respond to Trends

by Rob Meyer | Nov 2018 (Supply Chain Management) ... technologies and selecting materials that are not only cost-efficient, but provide the properties required for high-performance orthopaedic devices, including (but not limited to) desired mechanical performance, ... Read more »

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

by Julie Vetalice | Nov 2018 (Legal, Clinical & Regulatory) ... the system, up from 20% in the previous quarter. Wright is actively developing additional modules for the platform, including augmented reality, artificial intelligence and inter-op guidance. According ... Read more »

GEO CART Designed to Address Operating Room, Supply Chain Efficiency

by Rob Meyer | Nov 2018 (Research & Development) ... the O.R. suite. It contains 2,000+ GEO products, including the GEO cannulated bone screw with related instruments and the GEO hammertoe device. (Three more product offerings are in the development stage, ... Read more »

Medacta Invests in Personalized Medicine with Acquisition of Swiss Technology Company

by Mike Evers & Rob Meyer | Nov 2018 (Business Critical) ... extremities. Medacta believes that the software is an answer for all corrective osteotomies, including periacetabular and high tibial osteotomies. To further its commitment in personalized medicine, ... Read more »

Professional, Personal Success Linked to Knowing Yourself and Achieving Your Goals

by Rob Meyer | Nov 2018 (Business Critical) ... Ph.D., MBA, PEng, were both relevant and relatable to his OMTEC® 2018 audience earlier this year. Dr. Cornwall is eminently familiar with the orthopaedic device professional perspective. He worked at ... Read more »

ConnectSx Issued Patent for Integrated Device Management System

by BONEZONE | Nov 2018 (Supplier News Items) ... integrated platform aims to: Display a device’s UDI and critical information such as serial number, expiration, sterilization instructions or surgical technique guides through a mobile app (pictured ... Read more »

Orthopaedic Product Development: Forecasting Changes to Come

by Deborah Munro | Nov 2018 (Voice of Industry) ... researchers will soon be able to stimulate bone to repair itself. The need for orthopaedic fixation will still exist, but the design of those implants, including their materials, will change, as will ... Read more »

Synthetic Bioresorbables: Orthopaedics’ Evolution from PLLA to New Formulas

by Robert Poggie | Nov 2018 (Voice of Industry) ... for meshes and scaffolds based on weaving or knitting of fiber-based materials for repair and augmentation of soft tissues (excluding sutures), with one notable material being Poly-4-hydroxybutyrate (P4HB, ... Read more »

New Healthcare Investment Firm Mend Medical Debuts

by BONEZONE | Oct 2018 (Supplier News Items) ... e the company's investment strategy and interest in exploring partnerships that challenge our current care delivery models, including digital health and supply chain ideas. Mend Medical currently mana ... Read more »

Carpenter Technology Acquires LPW

by BONEZONE | Oct 2018 (Supplier News Items) ... to broadenits AM portfolio, including investments in Puris, a titanium powders producer, and CalRAM, a provider of electron beam and laser powder-bed fusion AM services, as well as construction of an Emerging ... Read more »

Smart Devices, Robotics, Sensors: Tools to Improve Patient Outcomes

by Julie Vetalice | Oct 2018 (Voice of Industry) ...  Intra-op sensors improve the surgeon’s ability to achieve soft tissue balance while performing a total knee arthroplasty (TKA). Multiple studies and a randomized, controlled trial have confirmed tha ... Read more »

Zimmer Biomet, Apple Collaboration Latest Example of Industry Focus on Digital Health

by Julie A. Vetalice & Rob Meyer | Oct 2018 (Business Critical) ... SMART technology in clinical studies, led by Dr. Mark I. Froimson, Immediate Past President of the American Association of Hip and Knee Surgeons. As the regulatory path conceivably gets smoother and ... Read more »

Five Star Companies Achieves ISO 13485:2016 Certification

by BONEZONE | Oct 2018 (Supplier News Items) ...  Five Star’s manufacturing capabilities include EDM; CMM; laser marking, engraving and welding; 5-axis CNC machining; and software including AutoCAD, SolidWorks and MasterCAM. Five Star also specializes ... Read more »

Materialise Launches Additive Simulation Software

by BONEZONE | Oct 2018 (Supplier News Items) ... a wider audience. Users can apply simulation results directly to the support generation and orientation tools in their Materialise Magics environment. The simulation software supports fast reruns on a ... Read more »

Flex-Cell Precision Gains ISO 13485:2016/9001:2015 Certifications

by BONEZONE | Oct 2018 (Supplier News Items) ... and is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.  ISO 9001:2015 specifies requirements for a quality ... Read more »

Corin Increases Footprint with Acquisition of Global Orthopaedic Technology

by Julie Vetalice | Oct 2018 (Business Critical) ... has grown through alliances that combine its hip and knee implants with computer-assisted-surgery systems, including: A 2015 collaboration with Materialise to use its 3D surgical planning software ... Read more »

Crucial Validation Considerations for Instrument Cases and Trays

by Rob Meyer | Oct 2018 (Legal, Clinical & Regulatory) ...  studies done at the higher end of these parameters (high temperature, pressure, most harsh detergents, and functional cycles applied) and this replicates possible excursions found throughout all Steril ... Read more »

NASS Conversations Reaffirm Focus on Additive, Computer-Assisted Surgery, Materials

by Carolyn LaWell | Oct 2018 (Business Critical) ...  NuVasive demonstrated its Pulse platform which incorporates multiple technologies, including the company’s neuromonitoring system, along with surgical planning, rod bending, imaging, navigation and ... Read more »

Orthobiologics for Fracture Repair, Knee Cartilage Defects: 3Q18 Study Highlights

by Julie A. Vetalice & Rob Meyer | Oct 2018 (Business Critical) Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we tracked that announced completed studies in the last three ... Read more »

11 Arthroscopy/Soft Tissue Repair Companies Worth Watching

by Julie Vetalice | Oct 2018 (Research & Development) ... 2018, the company closed a $1.5MM funding and affirmed plans for 2019 launch of human clinical studies. CartiHeal | Kfar Saba, Israel | Founded 2009 Agili-C Unicondylar Implant: A cell-free, off-the-shelf ... Read more »

Surgeon Entrepreneurs Focus on Infection Prevention, Virtual Reality Training

by Carolyn LaWell | Oct 2018 (Voice of Industry) ...  insert themselves into a virtual O.R. with all they need to perform a procedure. The remote technology allows for "post-op" performance assessment, including time/motion and instrument handling. “O ... Read more »

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

by Martin Browning | Oct 2018 (Legal, Clinical & Regulatory) ...  written response immediately. This assures that your response is seen by all interested parties, including the investigators’ supervisor (who is usually a district compliance officer) and to other higher-up ... Read more »

In’Tech Medical Commences Full Launch of Wayvio

by BONEZONE | Sep 2018 (Supplier News Items) ... inventory management tool allows device companies to locate instruments throughout the supply chain, from warehouse to O.R. Its mobile app features device identity tracking (a UDI requirement) and eases ... Read more »

Large Spine Players Focus Acquisitions on Robotics, Navigation, Additive

by BONEZONE | Sep 2018 (Business Critical) ... complements Globus’ 2Q18 purchase of KB Medical, developer of the AQrate Robotic Assistance system. Surgimap is widely used by Globus’ competitors, including DePuy Synthes, K2M, Medtronic, NuVasive, Orthofix, ... Read more »

25 Considerations for Companies Seeking Clarity in Design Controls

by John Gagliardi | Sep 2018 (Legal, Clinical & Regulatory) ... and assessment of these requirements.  Since early 1984, FDA has identified lack of design controls as one of the major causes of device recalls. The intrinsic quality of devices, including their safety ... Read more »

Effective Supplier Scorecards Rely on Identifying Key Metrics, Data, Inputs

by Julie Vetalice | Sep 2018 (Supply Chain Management) ... there programs or software that do a better job? Would these get looked at in an audit? Excel is an excellent tool that accommodates this activity for several reasons: it’s relatively easy to create, ... Read more »

AIRO Focuses on Robotic, Artificial Intelligence Application for Joint Reconstruction

by BONEZONE | Sep 2018 (Research & Development) ... require, including chondral regenerative procedures, partial resurfacing, total joint replacement and revision.  With whom does AIRO partner and collaborate? Robertson: At the core of our research ... Read more »

ACL Reconstruction Startup Secures Funding to Support IDE Clinical Trial

by Rob Meyer | Sep 2018 (Research & Development) ...  to MIACH, preclinical studies suggest that knees treated with BEAR have a significantly lower rate of arthritis than those treated with traditional ACL reconstruction. The company has initiated an ID ... Read more »

Danco Anodizing Expands Spinal Rod Capability

by BONEZONE | Sep 2018 (Supplier News Items) Danco is now able to provide a longitudinal line on both straight and curved rods.                              Danco Anodizing has announced capability ... Read more »

Wright Medical’s Acquisition of Cartiva Offers Boost for Lower Extremity Business

by Julie A. Vetalice & Rob Meyer | Sep 2018 (Business Critical) ...  to what Wright leadership described as a ~$420MM addressable market in the U.S. SCI is also entered in clinical studies for the treatment of first carpometacarpal joint osteoarthritis at the base of th ... Read more »

Stryker Moves to Strengthen Spine Business with $1.4 Billion Purchase of K2M

by Julie A. Vetalice & Rob Meyer | Sep 2018 (Business Critical) ... among the top three players in spine (excluding orthobiologics), stepping over NuVasive—thus, changing the lineup to #1) Medtronic, #2 DePuy Synthes, #3) Stryker, according to our estimates. (See Exhibit ... Read more »

LaVezzi Precision Receives ISO 13485:2016 Certification

by BONEZONE | Sep 2018 (Supplier News Items) ... is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.  Companies have until March 1, 2019 to update their ... Read more »

Renishaw, Ibex Engineering Open Additive Manufacturing Demo Center

by BONEZONE | Aug 2018 (Supplier News Items) ...  which allows visitors to work through the development of an AM machine build file including material parameter development. Renishaw is a precision engineering and manufacturing technologies compan ... Read more »

Lucideon Appoints Commercial Engineer for Healthcare

by BONEZONE | Aug 2018 (Supplier News Items) ... retrieval studies during her career, combining failure analysis techniques with clinical data in order to assess the performance and survivorship of joint replacement systems. Lucideon performs full ... Read more »

Senvol Awarded Grant by NIST for Additive Data

by BONEZONE | Aug 2018 (Supplier News Items) ... come from NIST’s various round-robin test studies, as well as from its AM Benchmark Test Series. The project will culminate with an integration between Senvol ML and NIST’s AM Material Database (AMMD) ... Read more »

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

by Julie Vetalice | Aug 2018 (Legal, Clinical & Regulatory) 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 ... Read more »

First Two United States Patients Receive CartiHeal’s Agili-C Implants

by Julie A. Vetalice & Rob Meyer | Aug 2018 (Research & Development) ... published in ORTHOKNOW®. “There are a number of technologies out there in clinical studies. …We put money into [CartiHeal] because we think [Agili-C] is good enough that we want to be part of it, but not ... Read more »

Carpenter Technology Names New VP, CFO

by BONEZONE | Aug 2018 (Supplier News Items) Timothy Lane has over 20 years of financial experience, including 11 years with Carpenter. Carpenter Technology, a global producer of alloy-based materials, powder metals and specialty wire for additive ... Read more »

Nelson Laboratories Purchases Gibraltar Laboratories

by BONEZONE | Aug 2018 (Supplier News Items) ... “The Gibraltar team is known for these values and also has an excellent reputation for designing specialized studies that help manufacturers prove the safety, efficacy and regulatory compliance of their ... Read more »

3D Systems Enters into Partnership with GF Machining Solutions

by BONEZONE | Aug 2018 (Supplier News Items) ...  3D Systems offers digital design and manufacturing solutions, including metal 3D printers used to create patient-specific implants for spinal and other applications. GF Machining Solutions is a provider ... Read more »

Medbio Acquired by Private Equity Firm

by BONEZONE | Aug 2018 (Supplier News Items) ... certified ISO Class 8 clean room for molding, along with several certified ISO Class 7 clean rooms for assembly and packaging. Medbio molds most medical grade thermoplastics, including implant-grade PEEK. ... Read more »

HAPPE Spine Latest Company to Manufacture PEEK Devices in Novel Ways

by Julie A. Vetalice & Rob Meyer | Aug 2018 (Business Critical) ...  Along with HAPPE, Genesis Innovation Group’s portfolio includes a number of orthopaedic companies including Shoulder Innovations, Magnesium Development, iMagen Orthopedics and Imascap. PEEK vs. titanium ... Read more »

Spinal Cages Continue Trend Toward Metals, Expandable Designs

by Rob Meyer | Aug 2018 (Voice of Industry) ...  spine cage technology to three veteran spine surgeons. While all three confirmed the shift to incorporate titanium, they also provided insight which we thought you would find interesting—including  ... Read more »

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

by Carolyn LaWell | Aug 2018 (Legal, Clinical & Regulatory) ... considerations for audits.                                            Mike Wolf Clinical data requirements tend to dominate conversations about the ... Read more »

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

by Carolyn LaWell | Aug 2018 (Legal, Clinical & Regulatory) ...  of re-uses). Cleanliness of Medical Parts, including removing power residue, has no standardized protocol or acceptance criteria. The recommendation is to develop standard test methods, metrics and acceptanc ... Read more »

Year-to-Date Funding Recap: Robotics, Imaging, ACL Implant, Cervical Disc and More

by BONEZONE | Jul 2018 (Business Critical) ... support commercialization of Nitinol-based cage technology, used to treat periarticular fractures in the proximal humerus. Medartis raised gross proceeds of CHF 123.9MM and CHF 142.6MM, including an ... Read more »

Empirical Celebrates 20th Anniversary

by BONEZONE | Jul 2018 (Supplier News Items) ...  Capabilities have broadened from testing to include regulatory expertise, consulting and a wide array of manufacturing processes, including prototyping, Swiss machining, multi-axis milling, grinding, ... Read more »