The Food and Drug Administration issued 56 orthopedic- and spine-related 510(k) clearances in March, according to an FDA report.
1. MSA Hip System from Global Manufacturing Technology.
2. Laguna Pedicle Screw System from Phygen.
3. Concorde Bullet Cage System from Johnson & Johnson.
4. Synthes MultiLoc Proximal Humeral Nailing System from Synthes.
5. Restoration Acetabular Wedge Augments from Howmedica Osteonics.
6. Zenith Pedicle System from Apollo Spine.
7. NuVasive Traverse Plate System from NuVasive.
8. Vanguard Removable Molded Poly Tibia from Biomet.
9. Biomet Sports Medicine Juggerknot Soft Anchor from Biomet.
10. 4.5MM VA-LCP Curved Condylar Plate System from Synthes.
11. Olecra Intramedullary Fixation System from Mylad Orthopedic Solutions.
12. Trio Trauma Spinal System from Stryker.
13. Fluoromap Software, 9" Fluorodisc (Belt), 12" Fluoro Disc (Belt), Close Tube Clip from Stryker.
14. Palla M Spinal System from Korea Bone Bank.
15. Symmetric Total Knee Augments from Signal Medical.
16. Quantum Spinal System, Quantum MIS from Pioneer Surgical Technology.
17. Aleutian from K2M.
18. Trinity Acetabular System from Corin U.S.A.
19. DePuy Corail Hip System, Revision System from DePuy Orthopaedics
20. Novel Tapered Hip Stem from Stryker.
21. Gryphon PEEK DS Anchor With OrthoCord from DePuy Mitek.
22. STCC from Cardinal Spine.
23. NewFix External Fixation system from Technologia Y Diseno Industrial.
24. TranS1 AxiaLIF+ from TranS1.
25. DePuy Attune Total Knee System from DePuy Orthopaedics.
26. Memometal Navis Bone Plating System from Memometal.
27. Anatomical Shoulder Combined System from Zimmer.
28. Altum Anterior Cervical Plate form SpineCraft.
29. Aaxter A3 Posterior Spinal System from Aaxter.
30. Escalade Acetabular Cup System from Ortho Development.
31. Accell Evo3 from Integra LifeSciences.
32. Flexfusion Fixation Implant from Nextremity Solutions.
33. Everest Spinal System from K2M.
34. Concorde Curve System from Johnson & Johnson.
35. Pezo Interbody Cage System from Ulrich.
36. Reverse Sacral Plates from Globus Medical.
37. AXSOS Locking Plate System from Stryker.
38. Low Profile Screws from Arthrex.
39. MPACT Acetabular System from Medacta.
40. JTS Extendable Implant from Stanmore Implants.
41. Valor Ankle Fusion Nail System Screw from Wright Medical Technology.
42. Forza Spacer System from Orthofix.
43. Lanx Lateral from Lanx.
44. SImmetry Sacroiliac Joint Fusion System from Zyga.
45. Pioneer Spinal Process Fusion Plate from Pioneer Surgical Technology.
46. Exp Acetabular Liner from StelKast.
47. Navitrack System – OS Knee Universal, CAS same Incision Tibia Reference from Zimmer.
48. Arcomxl Active Articulation from Biomet.
49. Balanced Knee System Revision Offset Tibia from Ortho Development.
50. GMK Revision Knee SC Liners from Medacta.
51. Lanx Spinal System from Lanx.
52. Syntec OS Spinal Fixation System from Syntec Scientific.
53. Apex PS Knee System from OMNI Life Science.
54. Capiva Spine FuseLox Cervical Cage from Capiva Spine.
55. Solus Anterior Lumbar Interbody Fusion Spinal Spacer System from Alphatec Spine.
56. Arthrex Biocomposite SutureTak from Arthrex.
Read full coverage on the medical devices approved by the FDA in March.
Read other coverage on orthopedic and spine device clearances:
- 45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January
- 36 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in February
1. MSA Hip System from Global Manufacturing Technology.
2. Laguna Pedicle Screw System from Phygen.
3. Concorde Bullet Cage System from Johnson & Johnson.
4. Synthes MultiLoc Proximal Humeral Nailing System from Synthes.
5. Restoration Acetabular Wedge Augments from Howmedica Osteonics.
6. Zenith Pedicle System from Apollo Spine.
7. NuVasive Traverse Plate System from NuVasive.
8. Vanguard Removable Molded Poly Tibia from Biomet.
9. Biomet Sports Medicine Juggerknot Soft Anchor from Biomet.
10. 4.5MM VA-LCP Curved Condylar Plate System from Synthes.
11. Olecra Intramedullary Fixation System from Mylad Orthopedic Solutions.
12. Trio Trauma Spinal System from Stryker.
13. Fluoromap Software, 9" Fluorodisc (Belt), 12" Fluoro Disc (Belt), Close Tube Clip from Stryker.
14. Palla M Spinal System from Korea Bone Bank.
15. Symmetric Total Knee Augments from Signal Medical.
16. Quantum Spinal System, Quantum MIS from Pioneer Surgical Technology.
17. Aleutian from K2M.
18. Trinity Acetabular System from Corin U.S.A.
19. DePuy Corail Hip System, Revision System from DePuy Orthopaedics
20. Novel Tapered Hip Stem from Stryker.
21. Gryphon PEEK DS Anchor With OrthoCord from DePuy Mitek.
22. STCC from Cardinal Spine.
23. NewFix External Fixation system from Technologia Y Diseno Industrial.
24. TranS1 AxiaLIF+ from TranS1.
25. DePuy Attune Total Knee System from DePuy Orthopaedics.
26. Memometal Navis Bone Plating System from Memometal.
27. Anatomical Shoulder Combined System from Zimmer.
28. Altum Anterior Cervical Plate form SpineCraft.
29. Aaxter A3 Posterior Spinal System from Aaxter.
30. Escalade Acetabular Cup System from Ortho Development.
31. Accell Evo3 from Integra LifeSciences.
32. Flexfusion Fixation Implant from Nextremity Solutions.
33. Everest Spinal System from K2M.
34. Concorde Curve System from Johnson & Johnson.
35. Pezo Interbody Cage System from Ulrich.
36. Reverse Sacral Plates from Globus Medical.
37. AXSOS Locking Plate System from Stryker.
38. Low Profile Screws from Arthrex.
39. MPACT Acetabular System from Medacta.
40. JTS Extendable Implant from Stanmore Implants.
41. Valor Ankle Fusion Nail System Screw from Wright Medical Technology.
42. Forza Spacer System from Orthofix.
43. Lanx Lateral from Lanx.
44. SImmetry Sacroiliac Joint Fusion System from Zyga.
45. Pioneer Spinal Process Fusion Plate from Pioneer Surgical Technology.
46. Exp Acetabular Liner from StelKast.
47. Navitrack System – OS Knee Universal, CAS same Incision Tibia Reference from Zimmer.
48. Arcomxl Active Articulation from Biomet.
49. Balanced Knee System Revision Offset Tibia from Ortho Development.
50. GMK Revision Knee SC Liners from Medacta.
51. Lanx Spinal System from Lanx.
52. Syntec OS Spinal Fixation System from Syntec Scientific.
53. Apex PS Knee System from OMNI Life Science.
54. Capiva Spine FuseLox Cervical Cage from Capiva Spine.
55. Solus Anterior Lumbar Interbody Fusion Spinal Spacer System from Alphatec Spine.
56. Arthrex Biocomposite SutureTak from Arthrex.
Read full coverage on the medical devices approved by the FDA in March.
Read other coverage on orthopedic and spine device clearances:
- 45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January
- 36 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in February