37 orthopedic devices approved in August

2022-08-20 05:07:59 By : Mr. Sam Chow

The FDA granted 37 orthopedic-related 510(k) device clearances last month.

1. Prime and Dynasty additive manufacturing shells from MicroPort Orthopedics 2. Moss VRS Spinal System from Biedermann Motech 3. Tyber Medical anatomic plating system from Tyber Medical 4. Impulse AM interbody fusion system from DeGen Medical 5. Dexa-C cervical interbody screw system from Aurora Spine 6. Inset reverse total shoulder system from Shoulder Innovations 7. CPM Medical Consultants tibial revision knee system from CPM Medical Consultants 8. Lateralized and augmented baseplates form FX Shoulder USA 9. IO expandable lumbar interbody fusion system from MiRus 10. Altus Spine Sochi OCT spinal system from Altus Partners 11. Excelsius3D from Globus Medical 12. Rosa hip system from Zimmer Biomet Spine 13. Prase-C anterior cervical plate system from GBS Commonwealth 14. Lateral Spine Truss System interbody fusion device from 4Web Medical 15. BEE PLIF Cage from NGMedical 16. Kheiron spinal fixation system from S.M.A.I.O 17. PAO cortical screw from Medacta Intl. 18. Triton sacroiliac joint fixation system from ChoiceSpine 19. Advantage-C PEEK cervical interbody fusion device from Intelivation 20. Alpha Vent PEEK suture anchor from Stryker Endoscopy 21. Attune medial stabilized fixed bearing insert from DePuy Ireland 22. ExcelsiusHub from Globus Medical 23. Emphasys femoral stems from DePuy Ireland 24. Journey II mid-level tibial inserts from Smith+Nephew 25. Insignia hip stem from Stryker Orthopaedics 26. Construx Mini PEEK spacer system / Construx Mini PEEK VBR System from Orthofix 27. Simplify Disc from NuVasive 28. PSX interbody system from Alphatec Spine 29. Quantum patient specific instrumentation system from In2Bones 30. BC Reflex Uni knee system from Bodycad Laboratories 31. Shoreline Threaded TruProfile plate from Seaspine Orthopedics 32. Quartex Occipito-Cervico-Thoracic spinal system and Globus navigation instruments from Globus Medical 33. Virage navigation system from Zimmer Biomet Spine 34. K&J IVA PEEK cage from K&J Consulting Corp. 35. KMTI S141 lumbar interbody fusion system from Kyocera Medical Technologies 36. Golden Isles pedicle screw system from Intelivation 37. Omni foot and ankle plating system from Extremity Medical

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