The Food and Drug Administration granted 43 orthopedic- and spine-related device clearances in January, according to an FDA report.
1. DNE External Fixation System from D.N.E.
2. Novation Integrip Acetabular Augments, Groups 4 and 5 from Exactech.
3. Dyna Locking Cannulated Screw from U&I Corp.
4. Focus MIS System from L&K Biomed Co.
5. OrthoScan Mobile DI Mini C-arm from OrthoScan.
6. Stryker Universal Neuro 3 System from Stryker.
7. Promos Modular Shoulder System from Smith & Nephew.
8. Smith & Nephew Unicompartmental and Bicompartmental Knee System Instruments
from Smith & Nephew.
9. Apex ARC Hip Stem from OmniLife Science.
10. Zimmer Patient Specific Instruments Planner from Materialize N.V.
11. Aptus Wrist Arthrosdesis Plates from MedArtis AG.
12. Labralink Suture Anchor With Inserter from Cayenne Medical.
13. ProPatch Soft Tissue Repair Matrix from CryoLife.
14. Aleutian System from K2M.
15. DSS Stabilization System from Paradigm Spine.
16. Suspension Clavicle Fracture Repair System from Suspension Orthopaedic Solutions.
17. Synergy Tissue Matrix from Synovis Orthopedic & Wound Care.
18. Comprehensive Reverse Shoulder Humeral Tray from Biomet.
19. OIC Cannulated Screw System, OIC Sliding Hip Screw System from The
Orthopaedic Implant Company.
20. Caspian from K2M.
21. Various from DePuy Mitek.
22. Pyrenees Cervical Plate System from K2M.
23. Cuffink from Cayenne Medical.
24. PEEK Prevail Cervical Interbody Device from Medtronic Sofamor Danek.
25. Leucadia Autolok Pedicle Screw System from Phygen.
26. Parcus Knotless PEEK CF Push-In Suture Anchors from Parcus Medical.
27. Nanovis Spinal System from Nanovis.
28. Oasys Spinal System from Stryker Spine.
29. Reliance Spinal Screw System from Reliance Medical Systems.
30. Smith & Nephew HealiCoil PK Suture Anchor from Smith & Nephew.
31. TwinFix Ultra, TwinFix Ultra HA Suture Anchors from Smith & Nephew.
32. Lexus Anterior Cervical Plate System from L&K Biomed.
33. OptiCage Interbody Fusion Device from Interventional Spine.
34. MTF New Bone Void Filler from Musculoskeletal Transplant Foundation.
35. Xenon Pedicle Screw System from Alphatec Spine.
36. Cardiff Anterior Cervical Plate System from SeaSpine.
37. Spineology PEEK Bullet Lumbar Interbody Device from Spineology.
38. Pioneer Release Laminoplasty Plating System from Pioneer Surgical Technology.
39. Hoffmann 3 Modular External Fixation System from Stryker.
40. Giza Vertebral Body Replacement from Eden Spine.
41. GMK Resurfacing Patella Size 4 from Medacta.
42. Santorini Spinal System from K2M.
43. Claw II Polyaxial Compression System and OrthoLoc 3DSI Locking Screws from
Wright Medical Group.
Related Articles on Device Clearances:
56 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in December
39 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in November
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in October
1. DNE External Fixation System from D.N.E.
2. Novation Integrip Acetabular Augments, Groups 4 and 5 from Exactech.
3. Dyna Locking Cannulated Screw from U&I Corp.
4. Focus MIS System from L&K Biomed Co.
5. OrthoScan Mobile DI Mini C-arm from OrthoScan.
6. Stryker Universal Neuro 3 System from Stryker.
7. Promos Modular Shoulder System from Smith & Nephew.
8. Smith & Nephew Unicompartmental and Bicompartmental Knee System Instruments
from Smith & Nephew.
9. Apex ARC Hip Stem from OmniLife Science.
10. Zimmer Patient Specific Instruments Planner from Materialize N.V.
11. Aptus Wrist Arthrosdesis Plates from MedArtis AG.
12. Labralink Suture Anchor With Inserter from Cayenne Medical.
13. ProPatch Soft Tissue Repair Matrix from CryoLife.
14. Aleutian System from K2M.
15. DSS Stabilization System from Paradigm Spine.
16. Suspension Clavicle Fracture Repair System from Suspension Orthopaedic Solutions.
17. Synergy Tissue Matrix from Synovis Orthopedic & Wound Care.
18. Comprehensive Reverse Shoulder Humeral Tray from Biomet.
19. OIC Cannulated Screw System, OIC Sliding Hip Screw System from The
Orthopaedic Implant Company.
20. Caspian from K2M.
21. Various from DePuy Mitek.
22. Pyrenees Cervical Plate System from K2M.
23. Cuffink from Cayenne Medical.
24. PEEK Prevail Cervical Interbody Device from Medtronic Sofamor Danek.
25. Leucadia Autolok Pedicle Screw System from Phygen.
26. Parcus Knotless PEEK CF Push-In Suture Anchors from Parcus Medical.
27. Nanovis Spinal System from Nanovis.
28. Oasys Spinal System from Stryker Spine.
29. Reliance Spinal Screw System from Reliance Medical Systems.
30. Smith & Nephew HealiCoil PK Suture Anchor from Smith & Nephew.
31. TwinFix Ultra, TwinFix Ultra HA Suture Anchors from Smith & Nephew.
32. Lexus Anterior Cervical Plate System from L&K Biomed.
33. OptiCage Interbody Fusion Device from Interventional Spine.
34. MTF New Bone Void Filler from Musculoskeletal Transplant Foundation.
35. Xenon Pedicle Screw System from Alphatec Spine.
36. Cardiff Anterior Cervical Plate System from SeaSpine.
37. Spineology PEEK Bullet Lumbar Interbody Device from Spineology.
38. Pioneer Release Laminoplasty Plating System from Pioneer Surgical Technology.
39. Hoffmann 3 Modular External Fixation System from Stryker.
40. Giza Vertebral Body Replacement from Eden Spine.
41. GMK Resurfacing Patella Size 4 from Medacta.
42. Santorini Spinal System from K2M.
43. Claw II Polyaxial Compression System and OrthoLoc 3DSI Locking Screws from
Wright Medical Group.
Related Articles on Device Clearances:
56 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in December
39 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in November
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in October