The Food and Drug Administration granted 46 spine- and orthopedic-related device clearances in October.
1. Everest Spinal System from K2M.
2. Neo Knee System from Pipeline Orthopedics.
3. Pass LP Spinal System from Medicrea International.
4. Nautilus Spinal System from Life Spine.
5. MagniFuse Bone Graft, MagiFuse II Bone Graft from Medtronic Sofamor Danek.
6. Locking Plate System from Beijing Libeier Bio-Engneering.
7. Avamax Vertebral Balloon System from CareFusion.
8. Reverse Shoulder Prosthesis Monoblock from Encore Medical.
9. STAXX IBL System from Spine Wave.
10. Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MM from Pivot Medical.
11. Comprehensive Reverse Shoulder – Titanium Glenosphere from Biomet Manufacturing.
12. Apex Knee Modular Tibia System from Omni Life Science.
13. Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System from Synthes.
14. CD Horizon Spinal System from Medtronic Sofamor Danek.
15. Anterior Lumbar Plate System (Presidio) from Life Spine.
16. Comprehensive Convertible Glenoid from Biomet Manufacturing.
17. Distal Radius Volar Rim Plate Standard, Narrow from Biomet.
18. Cezanne II Interbody Fusion System from Accel Spine.
19. T2 Tibial Nailing System from Stryker Trauma.
20. PolarStem Standard and Lateral Femoral Stems With TI/HA from Smith & Nephew.
21. Inertia MIS Pedicle Screw System from Nexxt Spine.
22. Idys LIF Cages from Clariance.
23. Implanet Spine System from Implanet.
24. Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella from Ortho Development.
25. Opetrak Logic PS 17MM & 19MM Thick Inserts from Exactech.
26. Pro Fusion from NLT Spine.
27. Ovation 10/12 Hip Stem from Ortho Development.
28. Aequalis Shoulder Fracture System, Reverse Shoulder Prosthesis from Thornier SAS.
29. AIM Suture Anchor from Anchor Innovation Medical.
30. iFuse Implant System from SI-BONE.
31. Univation from Aesculap Implant Systems.
32. True Spinal Fixation System from Innovative Surgical Designs.
33. Dyonics Plan Hip Impingement Planning System from Smith & Nephew.
34. No-Profile Screws, Washer from Biomet Sports Medicine.
35. Smith & Nephew Global Femoral Head Trials from Smith & Nephew.
36. Calix Lumbar Spinal Implant System from X-Spine Systems.
37. WMT Implantable K-Wire from Wright Medical Technology.
38. Variax 2 System from Stryker Trauma.
39. Lotus from Spinal Elements.
40. MAK OSS Femoral Knee Components from Biomet Orthopedics.
41. Marauder Cervical-Thoracic Spinal Fixation System from Intelligent Implant System.
42. Nautilus Spinal System from Life Spine.
43. Flower Bone Screw Set from Flower Orthopedics.
44. Spectrum Spine Fenestrated Facet Screw System from Spectrum Spine.
45. 2.5MM Inline Fusion Plate from Biomet.
46. Biolign ACIF Systems from Elite Surgical Supplies.
More Articles on FDA Clearances:
41 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in September
39 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in August
31 Spine & Orthopedic Devices Receiver FDA 510(k) Clearance in July