The Food and Drug Administration granted 56 orthopedic- and spine-related device clearances in December, according to an FDA report.
1. Acculif TL-PEEK IBF Cage from Coalign Innovations.
2. Renaissance System from Mazor Robotics.
3. Apex Modular Acetabular Cup from OmniLife Science.
4. Bendini Spinal Rod Bending System from NuVasive.
5. Synthes Cortical Screws from Synthes USA.
6. Axle PEEK Interspinous Fusion System from X-Spine Systems.
7. Ascension Atlas Humeral Plating System from Ascension Orthopedics.
8. Athena Pedicle Screw System from Royal Oak Medical Devices.
9. Shield Kyphoplasty System from Soteira.
10. VariLIFT Cervical Interbody Fusion System from Wenzel Spine.
11. Zavation Cervical Plate System from Zavation.
12. Modified RoG Suture Anchor from RoG Sports Medicine.
13. Genesys Spine Anterior Cervical Plate System from Genesys Spine.
14. Renovis Cannulated Screw System from Renovis Surgical Technologies.
15. SI-Lok Sacroiliac Joint Fixation System from Globus Medical.
16. OrthoLoc 3DSI Locking Screws from Wright Medical Technology.
17. Xingtm Spine System from Implanova.
18. Osteospring Footjack Subtalar Implant System from Osteospring Medical.
19. Synthes Zero-P from Synthes Spine.
20. VBB System from Synthes.
21. Headless Compression Screw from Skeletal Dynamics.
22. Interface Bone Void Filler from BioStructures.
23. Cougar System from Johnson & Johnson.
24. Staxx XD System from SpineWave.
25. 4-Web ALIF Spinal Truss System from 4-Web.
26. Lancer Pedicle Screw System from Spinal Solutions.
27. Arthrex Biocomposite Transfix from Arthrex.
28. Comprehensive Segmental Revision System from Biomet.
29. Aptus Distal Humerus System from Medartis.
30. ConforMIS iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
31. RoG Suture Anchor from RoG Sports Medicine.
32. PICO from Smith & Nephew.
33. Ace-Fischer, TempFix, Hoffman Classic External Fixators from DePuy Orthopaedics.
34. MSA Hip System from Global Manufacturing Technology.
35. Lanx Cervical SA from Lanx.
36. Reconstruction Locking Plate and 3.5MM Locking Screw from Xiamen Double Engline Medical Mate.
37. Comprehensive Reverse Shoulder from Biomet.
38. Spotlight Access System from Johnson & Johnson.
39. Ortho Solutions Trauma Implants for Osteosynthesis from Ortho Solutions.
40. Zimmer Plates and Screws System Screws Only from Zimmer.
41. Axsos Locking Plate System from Stryker.
42. Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
43. ACL Tightrope, ACL Tightrope Double Bundle from Arthrex.
44. Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilization Femoral Components from Smith & Nephew.
45. Healix Knotless Anchor from DePeuy Mitek.
46. Clydesdale Spinal System from Medtronic Sofamor Danek.
47. Medisiss Reprocessed Arthroscopic Shavers and Burs from Medisiss.
48. Limacorporate SMR Reverse Shoulder System from Limacorporate.
49. Arthrex Fracture System from Arthrex.
50. Range Spinal System (Mesa and Denali) from K2M.
51. Synthes MIRS from Synthes Spine.
52. Pencan Spinal Needle from B. Braun Medical.
53. Confidence High Viscosity Spinal Cement from Medos International.
54. Stryker Resorbable Fixation System from Stryker.
55. Zavation IBF Systems from Zavation.
56. SeaSpine Monopolar Probe System from SeaSpine.
Related Articles on FDA Clearances:
39 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in November
43 Orthopedic & Spine Devices Receive FDA 501(k) Clearance in October
35 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in September
1. Acculif TL-PEEK IBF Cage from Coalign Innovations.
2. Renaissance System from Mazor Robotics.
3. Apex Modular Acetabular Cup from OmniLife Science.
4. Bendini Spinal Rod Bending System from NuVasive.
5. Synthes Cortical Screws from Synthes USA.
6. Axle PEEK Interspinous Fusion System from X-Spine Systems.
7. Ascension Atlas Humeral Plating System from Ascension Orthopedics.
8. Athena Pedicle Screw System from Royal Oak Medical Devices.
9. Shield Kyphoplasty System from Soteira.
10. VariLIFT Cervical Interbody Fusion System from Wenzel Spine.
11. Zavation Cervical Plate System from Zavation.
12. Modified RoG Suture Anchor from RoG Sports Medicine.
13. Genesys Spine Anterior Cervical Plate System from Genesys Spine.
14. Renovis Cannulated Screw System from Renovis Surgical Technologies.
15. SI-Lok Sacroiliac Joint Fixation System from Globus Medical.
16. OrthoLoc 3DSI Locking Screws from Wright Medical Technology.
17. Xingtm Spine System from Implanova.
18. Osteospring Footjack Subtalar Implant System from Osteospring Medical.
19. Synthes Zero-P from Synthes Spine.
20. VBB System from Synthes.
21. Headless Compression Screw from Skeletal Dynamics.
22. Interface Bone Void Filler from BioStructures.
23. Cougar System from Johnson & Johnson.
24. Staxx XD System from SpineWave.
25. 4-Web ALIF Spinal Truss System from 4-Web.
26. Lancer Pedicle Screw System from Spinal Solutions.
27. Arthrex Biocomposite Transfix from Arthrex.
28. Comprehensive Segmental Revision System from Biomet.
29. Aptus Distal Humerus System from Medartis.
30. ConforMIS iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
31. RoG Suture Anchor from RoG Sports Medicine.
32. PICO from Smith & Nephew.
33. Ace-Fischer, TempFix, Hoffman Classic External Fixators from DePuy Orthopaedics.
34. MSA Hip System from Global Manufacturing Technology.
35. Lanx Cervical SA from Lanx.
36. Reconstruction Locking Plate and 3.5MM Locking Screw from Xiamen Double Engline Medical Mate.
37. Comprehensive Reverse Shoulder from Biomet.
38. Spotlight Access System from Johnson & Johnson.
39. Ortho Solutions Trauma Implants for Osteosynthesis from Ortho Solutions.
40. Zimmer Plates and Screws System Screws Only from Zimmer.
41. Axsos Locking Plate System from Stryker.
42. Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
43. ACL Tightrope, ACL Tightrope Double Bundle from Arthrex.
44. Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilization Femoral Components from Smith & Nephew.
45. Healix Knotless Anchor from DePeuy Mitek.
46. Clydesdale Spinal System from Medtronic Sofamor Danek.
47. Medisiss Reprocessed Arthroscopic Shavers and Burs from Medisiss.
48. Limacorporate SMR Reverse Shoulder System from Limacorporate.
49. Arthrex Fracture System from Arthrex.
50. Range Spinal System (Mesa and Denali) from K2M.
51. Synthes MIRS from Synthes Spine.
52. Pencan Spinal Needle from B. Braun Medical.
53. Confidence High Viscosity Spinal Cement from Medos International.
54. Stryker Resorbable Fixation System from Stryker.
55. Zavation IBF Systems from Zavation.
56. SeaSpine Monopolar Probe System from SeaSpine.
Related Articles on FDA Clearances:
39 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in November
43 Orthopedic & Spine Devices Receive FDA 501(k) Clearance in October
35 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in September