57 orthopedic devices receive FDA 510(k) clearance

Written by Laura Dyrda | September 11, 2017 | Print  |

The FDA granted 57 orthopedic-related device clearances in August.


1. CKS Plus Knee System from Consensus Orthopedics.


2. Infinity OCT System from Medtonic Sofamor Danek.


3. Locking Cage, Full XPE Cup from United Orthopedic Corp.


4. Noosa Anterior Lumbar Plate System; Nambucca Anterior Lumbar Plate System; Cairns Anterior Lumbar Plate System from Signature Orthopaedics.


5. FuzeFix Screw System from Fusion Orthopedics.


6. 3DMetal Tibial Cones from Medacta International.


7. TruMatch CMF Titanium 3D Printed Implant System from Materialise.


8. Gravity Soft Tissue Repair System from Wright Medical Technology.


9. Arix Foot System from Jeil Medical Corp.


10. NuVasive Less Ray with Enhanced Tracking from NuVasive.


11. MiniMax from Medacta International.


12. Anterior Spine Truss System Interbody Fusion Device from 4Web.


13. Premier from Shandong Weigao Orthopaedic Device.


14. Renovis S141 Lumbar Interbody Fusion System from Renovis Surgical Technologies.


15. Medacta Anatomic Shoulder Prosthesis from Medacta International.


16. The TiBow Expandable Spacer System from Life Spine.


17. Supplemental Instrument Trays from NuVasive Specialized Orthopedics.


18. Arix Ankle Fibula Hook Plate System from Jeil Medical Corp.


19. Latitude EV Total Elbow Arthroplasty from Tornier.


20. Calix-C Cervical Interbody Spacer from X-Spine Systems.


21. Matrixx System from Nexxt Spine.


22. OMNI Anseris Hip Stem from Omnilife Science.


23. OrthoPediatrics Titanium PediPlates System from OrthoPediatrics.


24. Procotyl Prime E-Class XLPE Liner from MicroPort Orthopedics.


25. OmniTom from NeuroLogica.


26. Entrada hip stem from Ortho Development Corp.


27. K2M Navigation Instruments from K2M.


28. Altus Spine Titanium Interbody Fusion System from Altus Partners.


29. M.U.S.T. Mini Posterior Cervical Screws System from Medacta International.


30. Evolution Revision CCK System from MicroPort Orthopedics.


31. Yukon OCT Spinal System from K2M.


32. Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems from ChoiceSpine.


33. Stryker Self-Punching Iconix from Stryker.


34. Zenius, Iliad and Kora Spinal Fixation Systems from Medyssey USA.


35. IRIX-A Lumbar Integrated Fusion System from X-Spine Systems.


36. Additional Viper Prime screws with fenestrations from Medos International.


37. M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System from Medacta International.


38. OKI Surgical Planning Software from Ortho Kinematics.


39. Excelsius GPS from Globus Medical.


40. ShurFit 2C Lumbar Interbody Fusion System from Precision Spine.


41. Duo Lumbar Interbody Fusion Device from Spineology.


42. Capri Corpectomy Cage System from K2M.


43. M.U.S.T. Combined Set Screws from Medacta International.


44. Magec System from NuVasive Specialized Orthopedics.


45. Jazz Passer Band from Implanet.


46. LigaPASS from Medicrea International.


47. Precice Unyte System from NuVasive Specialized Orthopedics.


48. Ozark Cervical Plate System from K2M.


49. Threshold V2 Pedicular Fixation System from Spineology.


50. Zimmer Natural Nail System from Zimmer.


51. 2 Hole Lateral Plating System from Life Spine.


52. Streamline OCT Occipito-Cervico-Thoracic System from Pioneer Surgical Technology.


53. Q-Fix Suture Anchor from ArthroCare.


54. CapSure PS System from Spine Wave.


55. Modified Winch Kyphoplasty 11 Gauge Balloon Catheters from G-21.


56. EVOS Small Fragment Plating System from Smith & Nephew.


57. VMA System version 3.0 from Ortho Kinematics.


More articles on orthopedic devices:

33 orthopedic devices receive FDA 510(k) clearance in July
48 orthopedic devices receive FDA 510(k) clearance in June
48 orthopedic devices receive FDA 510(k) clearance

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies here.

Featured Webinars

Featured Whitepapers