51 orthopedic devices receiving FDA premarket clearance in October

Spinal Tech

The FDA cleared 51 orthopedic devices last month.

 

1. Arthrex SoftStitch from Arthrex
2. Flower suture anchor set from Flower Orthopedics
3. Libertas E-XLPE modular liner from Maxx Orthopedics
4. Hexanium ACIF from SpineVision
5. Comprehensive shoulder system from Biomet
6. Mutars cemented femoral stems from Implantcast
7. MetaScope system from Medacta
8. Zavation IBF system from Zavation Medical Products
9. Telegraph Evolution humeral nailing system from FH Industrie
10. Unid IB3D ALIF from Medicrea
11. Expert – joint fixation system from GM dos Reis Industria e Comercio
12. G21 cement, Vader pedicle system from Icotec
13. Arthrosurface WristMotion total wrist arthroplasty system from Arthrosurface
14. LnK spinal fixation system, OpenLoc-L spinal fixation system from L&K Biomed
15. MySpine S2-Alar/Alar Ilar-Iliac pedicle screw placement guides from Medacta
16. LnK posterior cervical fixation system and CastleLoc-S posterior cervical fixation from L&K Biomed
17. AccelFix spinal fixation system from L&K Biomed
18. NuVasive Cohere thoracolumbar interbody system from NuVasive
19. Trivergent spinal fixation system from Benvenue Medical
20. Fortilink cages with TiPlus technology from Paradigm Spine
21. Cement bone void filler from BoneSupport
22. Icotec anterior cervical plate system from Icotec AG
23. Kheiron spinal fixation system from SMAIO
24. NuVasive Modulus XLIF interbody system from NuVasive
25. R3 HA coated acetabular shells from Smith & Nephew
26. Ossiofiber hammertoe fixation system / Ossiofiber hammertoe fixation implant from Ossio
27. Gaia lumbar interbody fusion device from PriterPrezz
28. Skeletal dynamics ulnar shortening plating system from Skeletal Dynamics
29. Dolomite anterior cervical stabilization system from Astura Medical.
30. NextAR TKA platform from Medacta
31. Oculus-SA lumbar cage system from Neurostructures
32. Materialise PKA guide system from Materialise
33. Atlas spine rebar spacer system from Atlas Spine
34. Epic anterior thoracolumbar plate system from Zimmer Biomet Spine
35. Invictus osseo screw system from Alphatec Spine
36. SpineJack expansion kit from Stryker
37. Mobio total knee system from b-One Ortho
38. ACTIS Duofix hip prosthesis from DePuy Orthopaedics
39. AOS Fibonacci lower extremity plating system from Advanced Orthopaedic Solutions
40. Anthem Fracture System from Globus Medical
41. OrthoNext Platform System from Orthofix
42. Cannulated power driver attachment from K2M
43. Construx mini PTC spacer system from Orthofix
44. OsteoMed ExtremiFix mini and small cannulated screw system from Osteomed
45. GEO bone screw system from Gramercy Extremity Orthopedics
46. IlluminOss bone stabilization system from IlluminOss Medical
47. Wiltrom spinal fixation system from Wiltrom
48. ARIX ankle distal tibia system from Jeil Medical
49. Syntec femoral mail extended system from Syntee Scientific
50. Construx Mini PEEK spacer system from Orthofix
51. Mazor X from Mazor Robotics

 

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