The FDA granted 34 orthopedic and spine related 510(k) clearances in January 2018.
1. Global Unite Platform Shoulder System from DePuy Ireland.
2. FMS Vue II Fluid Management and Tissue Debridement System from Medos International.
3. Alians Elbow Locking Plating System from Newclip Technics.
4. K2M Navigation Instruments from K2M.
5. Arrow Reverse Porous Glenoid from Fournitures Hospitalieres Industrie.
6. Stryker iVAS Elite Inflatable Vertebral Augmentation System from Stryker.
7. Guided Growth Plate System Plus from Orthofix.
8. Matisse Anterior Cervical Interbody Fusion Cage System, Ti-PEEK from CTL Medical.
9. Smith & Nephew Patient Matched Cutting Blocks from Smith & Nephew.
10. Arbor External Fixation System from Globus Medical.
11. Bone Screws 6.5mm from Lima Corporate.
12. Comprehensive Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate from Biomet.
13. Spineology Navigation Instruments from Spineology.
14. Wiltrom Spinal Fixation System from Wiltrom.
15. Forza XP Expandable Spacer System from Orthofix.
16. T2 Alpha Femur Antegrade GT/PF Nailing System from Stryker Trauma.
17. TiGer Shark System from ChoiceSpine.
18. Cervical Spinal Truss System Interbody Fusion Device from 4Web.
19. ChoiceSpine Laminoplasty Fixation System from ChoiceSpine.
20. Arthrex PushLock from Arthrex.
21. Reliance Lumbar IBF System from Reliance Medical Systems.
22. Evos Small Fragment Upper Extremity Plates from Smith & Nephew.
23. Ez Plate from Zavation Medical Products.
24. Navigated Infinity Instruments from Medtronic Sofamor Danek.
25. Zimmer Persona Personalized Knee System from Zimmer.
26. Titanium TL Curved Posterior Lumber Cage from Stryker.
27. Everest Spinal System from K2M.
28. SeaSpine Cabo Anterior Cervical Plate System from SeaSpine Orthopedics.
29. DIP Arthrodesis System from I2Bones.
30. Juliet Ti LL from Spineart.
31. DeGen Medical E3 MIS Pedicle Screw System from Degen Medical.
32. GENFlex2 Total Knee System – Ultra-Congruent CR Tibial Insert from StelKast.
33. Unity Total Knee System from Corin USA.
34. Centurion POCT System from Orthofix.
More articles on orthopedic devices:
59 orthopedic devices receive FDA 510(k) clearance in December
52 orthopedic devices receive FDA 510(k) clearance in November
40 orthopedic devices receive FDA 510(k) clearance in October