28 orthopedic devices approved by FDA in May

Spinal Tech

The FDA granted several knee, hip, shoulder and spine devices 510(k) clearance in May.

1. Link MobileLink acetabular cup system from Waldemar Link
2. Genius/Genuin total knee system from Biorad Medisys
3. Rebellion, Phantom multi-bite kerrison rongeur from Morpheus
4. Cuvis-spine from Curexo
5. BonOs Inject, pedicle screw kits and cement pusher from Osartis
6. Ignite anatomic shoulder system from Ignite Orthopedics
7. DRPx locking distal radius plate system from Orthopaedic Implant Company
8. Cap Spheres pellet pack from Zimmer Biomet Spine
9. Dart-Fire Edge cannulated screw system from Wright Medical
10. Blackhawk Ti cervical spacer system from ChoiceSpine
11. CoLink Sfx implant system from In2Bones USA
12. FuseForce Flex dynamic compression system from Wright Medical
13. Identity Imprint knee replacement system from Conformis
14. NuVasive Modulus expandable posterior lumbar MOD-EX PL interbody system from NuVasive
15. GII spinal fixation system from Coligne
16. Catalyft PL expandable interbody system from Medtronic Sofamor Danek
17. MOD-Ex XLIF interbody system from NuVasive
18. OrthoGold 100 from Tissue Regeneration Technologies
19. Actis DuoFix hip prosthesis-collarless from DePuy Ireland
20. iTotal Identity cruciate retaining knee replacement system from Conformis
21. Persona revision knee system femoral metaphyseal cones from Zimmer
22.Spinal screw system from Reliance Medical Systems
23. GMK Spherika femurs and fixed tibia tray plus from Medacta
24. LigaPass spinal system from Medtronic
25. External fixation system from Orthopaedic Implant Company
26. Legion CR porous plus HA femoral components from Smith+Nephew
27. Endoskeleton TC interbody system from Medtronic Sofamor Danek
28. Axis Charcot fixation system from Extremity Medical

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