The Food and Drug Administration issued 46 orthopedic and spine devices 510(k) clearances in January, according to an FDA report.
1. Congruent Bone Plate System from Acumed.
2. Multifit Total Hip System from Otis Biotech.
3. Hip Arthroscopy Repair Instrument Tray from Smith & Nephew.
4. Tibial Graftbolt from Arthrex.
5. Synthes 6.0 COCR and CPT TI-3 Rods from Synthes Spine.
6. Caliber Spacer from Globus Medical.
7. Spine Analyzer Model SAPOC from Optasia Medical.
8. Eclipse Vertebral Spacer System—Cervical from Apollo Spine.
9. Arthrex SwiveLock Anchors from Arthrex.
10. Stingray Cervical Cage; Shark Implant; Bull Shark Implant Tiger Implant; Great White Implant from Omni Surgical.
11. Evolution MP Total Knee System from Wright Medical Technology.
12. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
13. TRANSTED BR Anchor With ORTHOCORD, TRANSTED TI Anchor Cord with ORTHOCORD, TRANSTED PEEK Anchor with ORTHOCORD, HEALIX TRANSTEND from Depuy Mitek.
14. AlloFuse Plus from AlloSource.
15. Avamax Vertebral Balloon from CareFusion.
16. Trabecular Metal Fusion Device from Zimmer.
17. Eclipse Vertebral Spacer System—Lumbar from Apollo Spine.
18. GPS TM, G Surgical Anterior Cervical Plate System from G Surgical.
19. Patella Aspergillus from Bio-Rad.
20. Aequailis Ascend Modular Anatomic Shoulder System from Tornier.
21. Caspian Spinal System from K2M.
22. E1 Advantage Head from Biomet.
23. Hoffman II External Fixation System line expansion from Stryker.
24. OrthoFlex Rod from Ortho-Pro.
25. King Cobra Anterior Cervical Plate System from Eminent Spine.
26. ALIF Spinal Truss Interbody Fusion Device from 4-Web Spine.
27. VIPER System, EXPEDIUM System from DePuy Spine.
28. SP-Fix Spinous Process Fixation Plate from Globus Medical.
29. R3 XLPE Anteverted Liners from Smith & Nephew.
30. ES Trochanteric Nail, Left and Right, 10 MM from Advanced Orthopaedic Solutions.
31. Emerald Spinal System from Mazor Surgical Technologies.
32. Ortho Solutions Sterile, Drills, Taps, Guide Pins & Wires.
33. 2.4 MM VA-LCP Intercarpal Fusion System from Synthes.
34. TaperLoc Complete Size 5 and 6 from Biomet.
35. Exatech Proliant Polyaxial Pedicle Screw System from Exatech.
36. Kyphon Inflation Syringe from Medtronic.
37. Total Shoulder System from Shoulder Innovations.
38. Orthovita PEEK Spacer from Orthovita.
39. Lamenco Spinal Fixation System from Ulrich GMBH & Co.
40. Concensus Knee System from Consensus Orthopedics.
41. CD Horizon Spinal System from Medtronic Sofamor Danek.
42. OsteoRaptor II Suture Anchor from Smith & Nephew.
43. Lima-LTO SMR Shoulder System from Lima-LTO.
44. Smith & Nephew SMF Hip System.
45. Reverse Shoulder Prosthesis Monoblock Stem from Encore Medical.
Read the medical device clearances report from the FDA.
Read other coverage on FDA Clearances:
- 49 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in December
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November
1. Congruent Bone Plate System from Acumed.
2. Multifit Total Hip System from Otis Biotech.
3. Hip Arthroscopy Repair Instrument Tray from Smith & Nephew.
4. Tibial Graftbolt from Arthrex.
5. Synthes 6.0 COCR and CPT TI-3 Rods from Synthes Spine.
6. Caliber Spacer from Globus Medical.
7. Spine Analyzer Model SAPOC from Optasia Medical.
8. Eclipse Vertebral Spacer System—Cervical from Apollo Spine.
9. Arthrex SwiveLock Anchors from Arthrex.
10. Stingray Cervical Cage; Shark Implant; Bull Shark Implant Tiger Implant; Great White Implant from Omni Surgical.
11. Evolution MP Total Knee System from Wright Medical Technology.
12. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
13. TRANSTED BR Anchor With ORTHOCORD, TRANSTED TI Anchor Cord with ORTHOCORD, TRANSTED PEEK Anchor with ORTHOCORD, HEALIX TRANSTEND from Depuy Mitek.
14. AlloFuse Plus from AlloSource.
15. Avamax Vertebral Balloon from CareFusion.
16. Trabecular Metal Fusion Device from Zimmer.
17. Eclipse Vertebral Spacer System—Lumbar from Apollo Spine.
18. GPS TM, G Surgical Anterior Cervical Plate System from G Surgical.
19. Patella Aspergillus from Bio-Rad.
20. Aequailis Ascend Modular Anatomic Shoulder System from Tornier.
21. Caspian Spinal System from K2M.
22. E1 Advantage Head from Biomet.
23. Hoffman II External Fixation System line expansion from Stryker.
24. OrthoFlex Rod from Ortho-Pro.
25. King Cobra Anterior Cervical Plate System from Eminent Spine.
26. ALIF Spinal Truss Interbody Fusion Device from 4-Web Spine.
27. VIPER System, EXPEDIUM System from DePuy Spine.
28. SP-Fix Spinous Process Fixation Plate from Globus Medical.
29. R3 XLPE Anteverted Liners from Smith & Nephew.
30. ES Trochanteric Nail, Left and Right, 10 MM from Advanced Orthopaedic Solutions.
31. Emerald Spinal System from Mazor Surgical Technologies.
32. Ortho Solutions Sterile, Drills, Taps, Guide Pins & Wires.
33. 2.4 MM VA-LCP Intercarpal Fusion System from Synthes.
34. TaperLoc Complete Size 5 and 6 from Biomet.
35. Exatech Proliant Polyaxial Pedicle Screw System from Exatech.
36. Kyphon Inflation Syringe from Medtronic.
37. Total Shoulder System from Shoulder Innovations.
38. Orthovita PEEK Spacer from Orthovita.
39. Lamenco Spinal Fixation System from Ulrich GMBH & Co.
40. Concensus Knee System from Consensus Orthopedics.
41. CD Horizon Spinal System from Medtronic Sofamor Danek.
42. OsteoRaptor II Suture Anchor from Smith & Nephew.
43. Lima-LTO SMR Shoulder System from Lima-LTO.
44. Smith & Nephew SMF Hip System.
45. Reverse Shoulder Prosthesis Monoblock Stem from Encore Medical.
Read the medical device clearances report from the FDA.
Read other coverage on FDA Clearances:
- 49 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in December
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November