37 orthopedic devices receive FDA 510(k) clearance in February

Spinal Tech

The Food and Drug Administration granted 27 orthopedic and spine device-related clearances in February.

1. Sustain R Spacers, Patriot Spacers, Caliber Spacers, Rise Spacers, Coalition Spacers, Coalition AGX Spacers, Independence Spacers, Fortify-R Corpectomy Spacers, Fortify I-R Corpectomy Spacers, XPand-R Corpectomy Spacers, Niko Corpectomy Spacers, Monument Spacers, Altera Spacers, Magnify Spacers, InterCotninental Plate Spacer from Globus Medical.


2. SMR TT Metal Black Glenoid, Black Graft instruments from Lima Corporate.


3. Revision Femoral Stem from Lima Corporate.


4. Life Spine Metatarsal Hemi Implant from Life Spine.


5. Rasl Repair Kit from Radicle Orthopaedics.


6. U2 Total Knee System, PSA Tibial Insert from United Orthopedic Corp.


7. Sonoma Fifth Metatarsal Repair System from Sonoma Orthopedic Products.


8. DePuy Synthes from Synthes USA Products.


9. DCM Kyphoplasty System from Dragon Crown Medical.


10. AlignMATE Lapidus Arthrodesis System from ArthroSurface.


11. 4CIS Marlin ACIF Cage System from Solco Biomedical.


12. AxSOS 3 Ti; Stryker Plating System from Stryker.


13. Proficient Posterior Cervical Spine System from Spine Wave.


14. Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal from Custom Orthopaedic Solutions.


15. Exactech Equinoxe Preserve Stem from Exactech.


16. Spine Wave Anterior Cervical Spine System from Spine Wave.


17. Prophecy Invision Preoperative Navigation Alignment System from Wright Medical Technology.


18. Blueprint Patient Specific Instrument from Tornier.


19. Z-Span Plate System from Zavation.


20. VariAx Distal Radius Plating System, VariAx 2 System from Stryker.


21. Huvex Interspinous Fixation System from Dio Medical.


22. Exactech Equinoxe Humeral Reconstruction Prosthesis Extra Small Proximal Bodies from Exactech.


23. Atlas Spine Expandable Interbody System from Atlas Spine.


24. Stryker OrthoMap Versatile Hip System from Stryker.


25. Kyphon Xpede Bone Cement from Medtronic.


26. DePuy Synthes 2.4/2.7 mm LCP Two-Column Volar Distal Radius Plate, Extra Long from DePuy Synthes.


27. Revolution Spinal Fixation System from Intelligent Implant Systems.


28. Altus Spine Cervical Plate System from Altus Partners.


29. HA Minuteman G3-R MIS Fusion Plate from Spinal Simplicity.


30. Biomet Fusion System from Zimmer Biomet Spine.


31. Kepler I Cervical Plate System from Robbo Surgical.


32. ExpressBraid Graft Manipulation from Biomet.


33. ProMIS Fixation System from Premia Spine.


34. Fitmore Hip Stem from Zimmer.


35. Erisma LP Spinal Fixation System from Clariance SAS.


36. Truliant Femoral Components from Exactech.


37. Gravity PEEK-OPTIMA Suture Anchor from Wright Medical Technology.


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