The Food and Drug Administration granted 57 orthopedic- and spine-related clearances in October. 1. Novation LPI Prime Femoral Stem from Exactech.
2. Aft Proximal Humerus Fracture Plate from Shoulder Options.
3. Axsos Distal Lateral Femur TS Long Plates from Howmedica Osteonics Corp.
4. OrthoLoc 3DI Ankle Fusion Plating System from Wright Medical Group.
5. Tangors Multifunctional Posterior System from Ulrich GMBH & Co.
6. Reverse Stabilization System from Globus Medical.
7. AOS Solid Locking LAG Screw, AOS Telescopic Lag Screw from Advanced Orthopaedic Solutions.
8. Intrafix PEEK Tapered Screw from DePuy Mitek.
9. Geminus Fossa Specific Plate System from Skeletal Dynamics.
10. CD Horizon Spinal System from Medtronic Sofamor Danek.
11. Active Screw Bone Screw from Intelligent Implant Systems.
12. Tryptik CC Anterior Intersomatic Cervical Cage from Spineart.
13. Smith & Nephew Radiopaque Trial Necks from Smith & Nephew.
14. Tiger Spine System from Corelink.
15. Cross-Over Acetabular Shell & Liner from Stelkast Company.
16. Nextra TI Hammertoe Correction System from Nextremity Solutions.
17. Femoral Heads from United Orthopedic Corporation.
18. Zimmer Trabecular Metal Reverse Shoulder System from Zimmer.
19. AperFix AM Femoral Implant With Inserter from Cayenne Medical.
20. ProFemur Z Revision Hip System from Wright Medical Technology.
21. Archon Anterior Cervical Plate System from NuVasive.
22. Capsure PS System from Spine Wave.
23. Integrip Acetabular Shell, Integrip Revision Acetabular Shell from Exactech.
24. VisuALIF Challenging Access Plate form Spine Smith Partners.
25. Tregor Dual Mobility Acetabular System from Aston Medical.
26. Unisyn Plus Hip Stem from Consensus Orthopedics.
27. OrthoLoc 3DI Midfoot/Flatfoot System from Wright Medical Group.
28. iFuse Implant System from SI-BONE.
29. Smith & Nephew Redapt Revision Femoral System from Smith & Nephew.
30. Asfora Anterior Cervical Plate System from Medical Design.
31. Towerlox Pedicle Screw System from Captiva Spine.
32. Stingray Cervical Cage from Omni Surgical.
33. Cougar LS 15 Lateral Cage System from Medos International.
34. Smith & Nephew Ultra Fast-Fix Meniscal Repair System from Smith & Nephew.
35. 4-Web Cervical Spinal Truss System from 4-Web.
36. Venus Facet Screw System from Apollo Spine.
37. Oxford Fixed Lateral Bearing Partial Knee Replacement from Biomet.
38. Dynasty Biofoam Shell from Wright Medical Group.
39. Resolute Facet Screw System from Neurostructures.
40. Fortex Pedicle Screw System from X-Spine.
41. NuVasive Sage Lateral Plate System from NuVasive.
42. Biomet Lateral Spacer System from Biomet Spine.
43. Hoffmann 3 from Stryker.
44. Zenith, Femoral Stem Zenith, Distal Centralizer Femoral Head Acetabular Insert from TGM Medical.
45. Reliance Posterior Cervical-Thoracic System from Reliance Medical Systems.
46. Smith & Nephew SMF Hip Stem from Smith & Nephew.
47. Anchor-L Lumbar Cage from Stryker Spine.
48. GE 8CH Foot Ankle Coil from GE Hangwei Medical Systems.
49. FuseLox Lumbar Interbody Fusion Device from Captiva Spine.
50. Columbus Revision Knee System from Aesculap Implant System.
51. Rex Anterior Cervical Plate System from Dio Medical.
52. BioPro Hemi-Edge Toe System from BioPro.
53. AAP Loqteq Proximal Lateral Tibia Plate 4.5 System from AAP Implante.
54. Canopy Laminoplasty Fixation System from Globus Medical.
55. Quatro Link Knotless Anchor With Inserter from Cayenne Medical.
56. Stryker Universal Smartlock Hybrid MMF System from Stryker.
57. Certex Spinal Implant System from X-Spine Systems.
More Articles on Device Clearances:
37 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in September
32 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in August
40 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in July
2. Aft Proximal Humerus Fracture Plate from Shoulder Options.
3. Axsos Distal Lateral Femur TS Long Plates from Howmedica Osteonics Corp.
4. OrthoLoc 3DI Ankle Fusion Plating System from Wright Medical Group.
5. Tangors Multifunctional Posterior System from Ulrich GMBH & Co.
6. Reverse Stabilization System from Globus Medical.
7. AOS Solid Locking LAG Screw, AOS Telescopic Lag Screw from Advanced Orthopaedic Solutions.
8. Intrafix PEEK Tapered Screw from DePuy Mitek.
9. Geminus Fossa Specific Plate System from Skeletal Dynamics.
10. CD Horizon Spinal System from Medtronic Sofamor Danek.
11. Active Screw Bone Screw from Intelligent Implant Systems.
12. Tryptik CC Anterior Intersomatic Cervical Cage from Spineart.
13. Smith & Nephew Radiopaque Trial Necks from Smith & Nephew.
14. Tiger Spine System from Corelink.
15. Cross-Over Acetabular Shell & Liner from Stelkast Company.
16. Nextra TI Hammertoe Correction System from Nextremity Solutions.
17. Femoral Heads from United Orthopedic Corporation.
18. Zimmer Trabecular Metal Reverse Shoulder System from Zimmer.
19. AperFix AM Femoral Implant With Inserter from Cayenne Medical.
20. ProFemur Z Revision Hip System from Wright Medical Technology.
21. Archon Anterior Cervical Plate System from NuVasive.
22. Capsure PS System from Spine Wave.
23. Integrip Acetabular Shell, Integrip Revision Acetabular Shell from Exactech.
24. VisuALIF Challenging Access Plate form Spine Smith Partners.
25. Tregor Dual Mobility Acetabular System from Aston Medical.
26. Unisyn Plus Hip Stem from Consensus Orthopedics.
27. OrthoLoc 3DI Midfoot/Flatfoot System from Wright Medical Group.
28. iFuse Implant System from SI-BONE.
29. Smith & Nephew Redapt Revision Femoral System from Smith & Nephew.
30. Asfora Anterior Cervical Plate System from Medical Design.
31. Towerlox Pedicle Screw System from Captiva Spine.
32. Stingray Cervical Cage from Omni Surgical.
33. Cougar LS 15 Lateral Cage System from Medos International.
34. Smith & Nephew Ultra Fast-Fix Meniscal Repair System from Smith & Nephew.
35. 4-Web Cervical Spinal Truss System from 4-Web.
36. Venus Facet Screw System from Apollo Spine.
37. Oxford Fixed Lateral Bearing Partial Knee Replacement from Biomet.
38. Dynasty Biofoam Shell from Wright Medical Group.
39. Resolute Facet Screw System from Neurostructures.
40. Fortex Pedicle Screw System from X-Spine.
41. NuVasive Sage Lateral Plate System from NuVasive.
42. Biomet Lateral Spacer System from Biomet Spine.
43. Hoffmann 3 from Stryker.
44. Zenith, Femoral Stem Zenith, Distal Centralizer Femoral Head Acetabular Insert from TGM Medical.
45. Reliance Posterior Cervical-Thoracic System from Reliance Medical Systems.
46. Smith & Nephew SMF Hip Stem from Smith & Nephew.
47. Anchor-L Lumbar Cage from Stryker Spine.
48. GE 8CH Foot Ankle Coil from GE Hangwei Medical Systems.
49. FuseLox Lumbar Interbody Fusion Device from Captiva Spine.
50. Columbus Revision Knee System from Aesculap Implant System.
51. Rex Anterior Cervical Plate System from Dio Medical.
52. BioPro Hemi-Edge Toe System from BioPro.
53. AAP Loqteq Proximal Lateral Tibia Plate 4.5 System from AAP Implante.
54. Canopy Laminoplasty Fixation System from Globus Medical.
55. Quatro Link Knotless Anchor With Inserter from Cayenne Medical.
56. Stryker Universal Smartlock Hybrid MMF System from Stryker.
57. Certex Spinal Implant System from X-Spine Systems.
More Articles on Device Clearances:
37 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in September
32 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in August
40 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in July