The Transition to MDR and Important Considerations—An Orthopedic Innovators Q&A
With the delays seemingly settled, orthopedic device manufacturers need to ensure they are aligned to the EU’s MDR.
Regulatory & Legal
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3-D Printing/Additive Mfg. | Extremities
AAOS24: First 3D Printed Toe Joint Replacement Being Showcased
Anatomic Implants has patented and developed the first metatarsophalangeal joint replacement that nearly perfectly replicates the human anatomy.Michael Barbella, Managing Editor 02.07.24
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Large Joint
AAOS Updates Clinical Practice Guideline for Managing Hip Osteoarthritis
Updated guideline offers the latest in evidence-based research to reduce pain, expand function, and improve quality of life.Michael Barbella, Managing Editor 02.06.24
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Extremities
FDA Warns of Possible Equinoxe Shoulder Implant Wear and Tear
Defective packaging could cause the Exactech implants to degrade faster over time.Sam Brusco, Associate Editor 01.17.24
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Large Joint
FDA: Do Not Use Synovo Total Hip Resurfacing System
Modifications not cleared by the FDA were made to devices manufactured after 2019.Sam Brusco, Associate Editor 01.04.24
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Spine/Neurology
Life Spine Notches Legal Win Against Aegis Spine
Aegis is now barred from selling its AccelFIX-XT line of devices in the U.S.Sam Brusco, Associate Editor 01.02.24
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Medimaps Group Achieves EU Certification Under MDR
Through the MDR, Medimaps Group increased the robustness of its clinical evaluation, technical design, and post-market surveillance.Michael Barbella, Managing Editor 11.14.23
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Biocompatibility & Testing
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AAOS Comments on Info Request for Episode-Based Payment Model
In a letter, AAOS expressed its support for engaging physicians in designing and implementing alternative payment models.Michael Barbella, Managing Editor 08.25.23
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RevBio Granted ISO 13485 Certification
Company's bone adhesive was tested last year on the International Space Station.Michael Barbella, Managing Editor 08.21.23
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Spine/Neurology
FDA Grants Clearance to CTL Amedica's NITRO Interbody Fusion Cage System
Product's material has unique bacteriostatic properties, provides artifact-free imaging, and is compatible with all imaging modalities.Michael Barbella, Managing Editor 08.15.23
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AAOS Releases New Guidance to Simplify Patient-Reported Outcome Measures in Practice
New interactive, high-quality tools help orthopedic surgeons collect patient data in advance of mandatory reporting periods.Michael Barbella, Managing Editor 08.07.23
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Biologics
Aziyo Biologics Issues Voluntary Recall of Viable Bone Matrix Products
Recall trigged by reports of post-surgical infections in two patients.Michael Barbella, Managing Editor 07.14.23
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AAOS Releases New Appropriate Use Criteria
The guidelines target shoulder osteoarthritis treatment.Michael Barbella, Managing Editor 07.12.23
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Spine/Neurology
NASS Recommends Basivertebral Nerve Ablation as a Low Back Pain Treatment
The policy proactively defines appropriate coverage positions based on the effectiveness of BVN ablation as a treatment option.Michael Barbella, Managing Editor 05.15.23
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Biocompatibility & Testing
The MDR Delay’s Impact on Regulatory and Testing—An Orthopedic Innovators Q&A
While the recent MDR delay gives companies some breathing room, it should not stall their effort in ensuring their products remain compliant for the EU.
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Extremities
Treace Medical, Fusion Ortho Settle IP Lawsuit
The terms of the settlement were not released.Sam Brusco, Associate Editor 03.03.23
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AAOS Updates CPG for Surgical Management of Knee Osteoarthritis
Updated guideline offers the latest in evidence-based research to improve surgical success and reduce complications, postoperative pain.Michael Barbella, Managing Editor 03.01.23
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Conformis, Bodycad Laboratories Settle Patent Litigation
Settlement resolves ongoing dispute that began in June 2021.Michael Barbella, Managing Editor 02.16.23
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3-D Printing/Additive Mfg. | Instruments
Reflections on 2022 and What’s Ahead for Orthopedic Technology: ODT Sounding Board
Several members of the ODT editorial advisory board share their thoughts on the headlines of 2022 and what’s coming in 2023.Online Exclusives Sean Fenske, Editor-in-Chief 12.01.22
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Breast Cancer Survivor Living Near Medical Sterilization Plant Awarded $363M
Sterigenics vows to appeal the decision.Michael Barbella, Managing Editor 09.22.22
