37 orthopedic devices approved in August

Laura Dyrda -  

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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