Monday, April 19, 2010

510(K) Approvals for March 2010

Aesculap: Hydrolift VBR System
Biomet: Solitaire PEEK Anterior Spinal System
K2M: Chesapeake Spinal System
K2M: Pyrenees Cervical Plate, Semi-Constrained Screws
LDR Spine: USA Spine Tune Ti Spine System
Medicrea: Impix Manta Cervical Interbody Device
Medicrea: Pass LP Spinal System
Spineart: Romeo Posterior Osteosynthesis System
Spinecraft: Apex Spine System 5.5mm Ti Rod & Polyaxial Screw Washer
Spinefrontier: Indus Anterior Cervical Plate
Stryker: AVS Align PEEK Spacers
Stryker: Modification to Oasys Posterior Cervical System
Synthes: Matrix MIS Rods
Zimmer: Trabvecular Metal VBR Replacement System Instrument Set


  1. This is my favorite part of this blog, MM...thank you and keep them coming!

  2. Here is a few more...some duplicates from the original:
    The FDA issued 49 orthopedic- and spine-related 510(k) clearances in March, according to a report by the FDA.

    1. Disposable circular stapler, models WHY-25, WHY-29, WHY-32, from Changzhou Waston Medical Appliances
    2. Pro-Fix precision fixation system model PFM#, PFB#, PFT# from Osteogenics Biomedical
    3. C-MOR Visualization Device from Axis Surgical Technologies
    4. A-GRIX resorbable bone void filled from AG Digital Technology
    5. Medacta bipolar head from Medacta International
    6. Synthes external fixation devices from Synthes
    7. DJO Surgical Revision Femoral Hip System, model 428-14/24-140/200; 428-00-050/110, from Encore Medical
    8. Aesculap Hydrolift VBR System from Aesculap
    9. Trabecular Metal vertebral body replacement system instrument set from Zimmer
    10. Vericore abutment in titanium for implant systems from Whip-Mix
    11. Smith & Nephew Footprint Ultra PK suture anchor from Smith & Nephew Endoscopy
    12. Evolution MP total knee system from Wright Medical Technology
    13. Pass LP Spinal System from Medicrea Technologies
    14. Chesapeake Spinal System from K2M
    15. Biosure Sync tibial fixation device, in 6mm, 8mm, 10mm and 12mm sizes, from Smith & Nephew Endoscopy
    16. Tibial Baseplate Augment, models KC-22118, KC-22128, KC-22138, KC-22148, KC-22158, from Omni Life Science
    17. Optilock variable-angle locking distal radius plating system from Biomet Trauma
    18. Stryker Arthroscope from Stryker Endoscopy
    19. Synthes Matrix rods from Synthes
    20. Solitaire and Solitaire Peek anterior spinal system from Biomet Spine
    21. TC plating system from Ortho-Pro
    22. Fixit headrest clamp system from Medicon
    23. Pyrenees cervical plate system, semi-constrained screws from K2M
    24. AVS Alight Peek spacers model 48328XXX, 48326XXX from Stryker
    25. MBCP+ from Biomatlante
    26. Spinal guides PACS from Albert Davydov
    27. Apaex spine system 5.50mm titanium rod & polyxial screw washer from Spinecraft
    28. Neuroscout steerable guidewire from Codman & Shurtleff
    29. Impix Manta cervical interbody device from Medicrea
    30. Omnitech large Trimed compression screw from Trimed
    31. Versalock peek anchor with Orthocord suture, models 210818 and 210819, from Depuy Mitek
    32. Versaclose model VC-200-01 from Anulex Technologies
    33. Arthrex tibial graftbolt from Arthrex
    34. Bio-Oss collagen from Ed. Geistlich Soehne
    35. Modification to Oasys System from Stryker Spine
    36. Medpor Contain implant from Porex Surgical
    37. Reprocessed trocars, models B5LT and CB5LT, from Ascent Healthcare Solutions
    38. Opus Speedscrew system from Arthrocare
    39. SMPLE plate and screws from Biomet Trauma
    40. Kneealign system with reference sensor from Orthalign
    41. BI-Ostetic foam and putty, Generos foam and putty from Berkeley Advanced Biomaterials
    42. Incite Inovation stand-alone interbody fusion device from Incite Innovation
    43. Indus anterior cervical plate system from Spinefrontier
    44. G-Force TI suture anchor system from Wright Medical Technology
    45. GPC bone plates and bone screw & GPC DHS/DCS plate system from GPC Medical
    46. Synthes 3.5mm quadrilateral surface plates from Synthes
    47. Synthes sternal fixation system from Synthes
    48. Apex-LNK acetabular insert E & F and Apex-LNK from Omni Life Science.
    49. LDR Spine USA Spine Tune TL spine system from LDR Spine USA