The Food and Drug Administration granted 52 orthopedic- and spine-related device exemptions in July.
1. Choice Spine Lumbar Spacer System from Choice Spine.
2. Excia Total Hip System from Aesculap Implant Systems.
3. Skyhawk Lateral Plate System from Orthofix.
4. Endoskeleton TL Interbody Fusion Device from Titan Spine.
5. View Plating System, Reduce Fracture Plating System, Bone Screw from Icon Orthopedic Concepts.
6. Aesculap Optilene Nonabsorbable Suture from Aesculap.
7. Range/Mesa/Denali Spinal System from K2M.
8. Restoris Porous Partial Knee System from MAKO Surgical.
9. FixFit Intervertebral Body Fusion Device from Expanding Orthopedics.
10. Biofoam Bone Wedge from Wright Medical Technology.
11. Endowrist Stapler 45 and Stapler 45 Reloads from Intuitive Surgical.
12. Arthrosurface KISSLOC Knotless Suture System from Arthrosurface.
13. Optetrak Logic Porous Femoral Components from Exactech.
14. IRIX-A Lumbar Integrated Fusion System from X-Spine Systems.
15. iFuse Implant System from SI-BONE.
16. Coroent XL-F System from NuVasive.
17. MLX-Medial Lateral Expandable Lumbar Interbody System from NuVasive.
18. Milestone Spinal System from Weigo Orthopaedic Device.
19. Coroent Small Interbody System from NuVasive.
20. DuaFit Interphalangeal Implant PEEK Fuse Interphalangeal Implant from In2Bones.
21. Caspian OCT Spinal System from K2M.
22. Ortho Solutions Ultos Plating System from Ortho Solutions.
23. AP Expandable XLIF System from NuVasive.
24. PLIF Lite and TLIF Lite from SinteaPlustek.
25. Alpine Hip Stem; Alpine HA Hip Stem from Ortho Development.
26. Aequalis Ascent Flex Shoulder System from Tornier.
27. K2M Modular Hooks from K2M.
28. Porous Coated Comprehensive Fracture Stems from Biomet.
29. PediLoc Fragment System from Orthopediatrics.
30. Kangli from Suzhou Kangli Orthopaedics Instruments.
31. VeloxInterbody Fusion System from U&I Corp.
32. Gryphon BR Anchor W/ProKnot Technology, Gryphon PEEK Anchor W/ProKnot Technology from DePuy Mitek.
33. Consensus Vitalite Tibial Insert from Consensus Orthopedics.
34. JuggerLoc Bone to Bone Implants from Biomet.
35. AOS 6.5MM Captured, Fully Threaded Cancellous Screw from Advanced Orthopaedic Solutions.
36. Altera Spacer from Globus Medical.
37. C-Jaws Cervical Compressive Staple from Medicrea International.
38. Variax Elbow Plating System from Stryker Trauma.
39. BiosureHelicoil PK Interference Screw from Smith & Nephew.
40. PFX Spinous Process Fixation System from Innovasis.
41. Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, evolve Masters Hip from Signature Orthopaedics.
42. Arthrex PIP Dart from Arthrex.
43. Navio from Blue Belt Technologies.
44. Alteon 6.5MM Bone Screws from Exactech.
45. Variax Distal Radius Plating System from Stryker Leibinger GmbH & Co.
46. Caspian Spinal System from K2M.
47. Divergence Mini-Plate Anterior Cervical Fusion System from Medtronic.
48. Vanguard 360 Osseo Tibial Sleeve Augment from Biomet.
49. G-Force Gen 2 Suture Anchor System from Wright Medical.
50. Humelock II Cemented Shoulder System from FX Solutions.
51. CD Horizon Spinal System from Medtronic Sofamor Danek.
52. Arthrex Fracture Plates and Screws from Arthrex.
More articles on FDA clearances:
35 spine, orthopedic devices receive FDA 510(k) clearance in June
39 spine, orthopedic devices receive FDA 510(k) clearance in May
44 spine, orthopedic devices receive FDA 510(k) clearance in April