The Food and Drug Administration granted 38 orthopedic- and spine-related medical device clearances in March.
1. Restoris Partial Knee Application from MAKO Surgical.
2. Knotless Anchor System from T.A.G. Medical Products.
3. PLIF Cage from Eisertech.
4. Footprint Ultra PK Suture Anchor from Smith & Nephew.
5. Leucadia 4.5 MM Pedicle Screw System from Phygen.
6. Power Adaptor Instrument Accessory from Stryker.
7. Arthrex UniversII XL Glenoid-Pegged, Gelnoid-Keeled from Arthrex.
8. Ascend Shoulder System from Tornier.
9. Lanx Spinal Fusion System from Lanx.
10. Pipeline Total Hip System from Pipeline Orthopedics.
11. Reliance Lumbar IBF System from Reliance Medical Systems.
12. Trauma Internal Fixation Systems from DePuy Orthopaedics.
13. Pioneer Posterior Cervico Thoracic System from Pioneer Surgical.
14. Enhantch Orthopaedics Patient/Technique Specific Humeral from Enhatch Orthopaedics.
15. Aequalis Shoulder Fracture System, Reversed Shoulder Prosthesis, Reversed Shoulder Fracture Prosthesis from Tornier.
16. NuVasive Coroent No-Profile System from NuVasive.
17. Aileron Interspinous Fixation System from Life Spine.
18. Asfora Bullet Cage from Medical Designs.
19. Foundation Spinal System from The Skeletal Design Partnership.
20. Synster Cervical Cage, ALIF Cage, PLIF Cage, PTLIF Cage, TLIF Cage from BM Korea.
21. Highly Cross Linked VE Central Peg Patella from Encore Medical.
22. Synthes Variable Angle LCP Elbow System from Synthes.
23. Citieffe Titanium Nailing System from Citieffe.
24. NuVasive NVM5 System from NuVasive.
25. Novation Element Femoral Stem from Exactech.
26. Chesapeake Spinal System from K2M.
27. Metha Hip System from Aesculap Implant Systems.
28. Solitaire PEEK Anterior Spinal System from Biomet Spine & Bone Healing Technology.
29. Newdeal Interphalangeal Implant System from Newdeal.
30. Biobolt from Arthrex.
31. Zavation IBF System from Zavation.
32. Ellipse Precice Trauma Nail System from Ellipse Technologies.
33. Zimmer Personal Knee System from Zimmer.
34. MultiFix Knotless Fixation Device from ArthroCare
35. Venus Spinal Fixation System from L&K Biomed.
36. Palls Spinal System from Korea Bone Bank Co.
37. Apaceram Bone Graft Substitute from Hoya Corporation.
38. Small and Large Fragments Osteosynthesis System Neofix from NeoOrtho Produtos Ortopedicos.
More Articles on Orthopedic Device Clearances:
44 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in February
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in January
56 Orthopedic & Spine Devices Receives FDA 510(k) Clearance in December
1. Restoris Partial Knee Application from MAKO Surgical.
2. Knotless Anchor System from T.A.G. Medical Products.
3. PLIF Cage from Eisertech.
4. Footprint Ultra PK Suture Anchor from Smith & Nephew.
5. Leucadia 4.5 MM Pedicle Screw System from Phygen.
6. Power Adaptor Instrument Accessory from Stryker.
7. Arthrex UniversII XL Glenoid-Pegged, Gelnoid-Keeled from Arthrex.
8. Ascend Shoulder System from Tornier.
9. Lanx Spinal Fusion System from Lanx.
10. Pipeline Total Hip System from Pipeline Orthopedics.
11. Reliance Lumbar IBF System from Reliance Medical Systems.
12. Trauma Internal Fixation Systems from DePuy Orthopaedics.
13. Pioneer Posterior Cervico Thoracic System from Pioneer Surgical.
14. Enhantch Orthopaedics Patient/Technique Specific Humeral from Enhatch Orthopaedics.
15. Aequalis Shoulder Fracture System, Reversed Shoulder Prosthesis, Reversed Shoulder Fracture Prosthesis from Tornier.
16. NuVasive Coroent No-Profile System from NuVasive.
17. Aileron Interspinous Fixation System from Life Spine.
18. Asfora Bullet Cage from Medical Designs.
19. Foundation Spinal System from The Skeletal Design Partnership.
20. Synster Cervical Cage, ALIF Cage, PLIF Cage, PTLIF Cage, TLIF Cage from BM Korea.
21. Highly Cross Linked VE Central Peg Patella from Encore Medical.
22. Synthes Variable Angle LCP Elbow System from Synthes.
23. Citieffe Titanium Nailing System from Citieffe.
24. NuVasive NVM5 System from NuVasive.
25. Novation Element Femoral Stem from Exactech.
26. Chesapeake Spinal System from K2M.
27. Metha Hip System from Aesculap Implant Systems.
28. Solitaire PEEK Anterior Spinal System from Biomet Spine & Bone Healing Technology.
29. Newdeal Interphalangeal Implant System from Newdeal.
30. Biobolt from Arthrex.
31. Zavation IBF System from Zavation.
32. Ellipse Precice Trauma Nail System from Ellipse Technologies.
33. Zimmer Personal Knee System from Zimmer.
34. MultiFix Knotless Fixation Device from ArthroCare
35. Venus Spinal Fixation System from L&K Biomed.
36. Palls Spinal System from Korea Bone Bank Co.
37. Apaceram Bone Graft Substitute from Hoya Corporation.
38. Small and Large Fragments Osteosynthesis System Neofix from NeoOrtho Produtos Ortopedicos.
More Articles on Orthopedic Device Clearances:
44 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in February
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in January
56 Orthopedic & Spine Devices Receives FDA 510(k) Clearance in December