The Food and Drug Administration granted 41 spine- and orthopedic-related device clearances in September.
1. VariLIFT-L Interbody Fusion Device from Wenzel Spine.
2. Ardis Interbody System from Zimmer Spine.
3. Prelude PF Femoral Components from Biomet.
4. U-Motion II PS+ Cut from United Orthopedic.
5. Interfuse L Intervertebral Body Fusion Device from Vertebral Technologies.
6. Spinal Intervertebral Body Fixation Orthosis from Accel Spine.
7. Integra Interspinous Process System from SeaSpine.
8. Polaris Spinal System from Biomet Spine.
9. Sequoia Pedicle Screw System Including SpeedLink II Traverse Connector System from Zimmer Spine.
10. Acumed Wrist Spanning Plate from Acumed.
11. Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System from Medos International.
12. Comprehensive Reverse Shoulder Screws from Biomet.
13. Tiger Spine System from CoreLink.
14. Retrograde Femoral Nail from Advanced Orthopaedic Solutions.
15. Expedium Viper, Viper 2 Spine System from DePuy Spine.
16. AccuLIF and PL Cage from Coalign Innovations.
17. CAS PSI Knee System from OrthoSoft.
18. Logic Stand-Alone Intervertebral Body Fusion Device from Binder Bimedical.
19. DePuy Corail AMT Hip Prosthesis from DePuy France.
20. NovoKnee Total Knee System from NovoSource.
21. Rampart-O, Rampart-T from Spineology.
22. Zimmer National Nail System Tibial Nail and Stainless Steel Tibial Nail from Zimmer.
23. Maxlock Extreme System from OrthoHelex Surgical Designs.
24. 5.5MM & 6.5MM Multifix S. Knotless Fixation Device from ArthroCare.
25. Anterior Lumbar Interbody Fusion System from Renovis Surgical Technologies.
26. Zimmer MotionLoc Screw for Periarticular Locking Plate System from Zimmer.
27. Renovis Bipolar Hip System from Renovis Surgical Technologies.
28. Opticage Interbody Fusion Device from Interventional Spine.
29. Pipeline Total Hip System from Pipeline Biotechnology.
30. Tornier Insite FT Suture Anchor With Needles from Tornier.
31. Q-Fix Suture Anchor 1.8MM and 2.8MM from ArthroCare.
32. Lospa IS Pedicle Screw from Corentec.
33. CoRoent Single Tab System from NuVasive.
34. Reliance Cervical IBF System from Reliance Medical Systems.
35. Anatomic PEEK Cervical Fusion System from Medtronic Sofamor Danek.
36. T2 XVBR Spinal System from Medtronic Sofamor Danek.
37. Arthrex Compression Plates from Arthrex.
38. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.
39. Trinity Acetabular System from Corin USA.
40. Arthrex Universe APEX from Arthrex.
41. Tyber Medical Interbody System ACIF, ALIF, PLIF, TLIF, DLIF from Tyber Medical.
More Articles on FDA Clearances:
39 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in August
31 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in July
40 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in May