Triathlon Tibial Baseplate

  • Modèle / numéro de série
    # 4 - Catalog Number: 5520-B-400, Lot code: SH8NT; # 2 - Catalog Number: 5520-B-200, Lot Code SH7RP.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: AL, AZ, CA, MT, NJ and TX.
  • Description du dispositif
    Triathlon Total Knee System Primary Tibial Baseplate; || Sterile, Made in Ireland. || Howmedica Osteonics || 325 Corporate Drive || Mahwah, NJ 07430 || The Triathlon system is comprised of a femoral component, tibial tray, and tibial insert that are intended to be used in total knee arthroplasty (if replacement of the articular surf ace of the patella is required, the Duracon patellar components are compatible with the Triathlon components). The Triathlon PS Total Knee System is intended to be used in situation where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon All Polyethylene patellare components are intended to be used with the femoral components of the previously released Duracon Total Knee System, as well as the previously release Triathlon PS Femoral component in situation where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee system is intended to accommodate the posterior cruciate ligament (PCL) if it is present.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
  • Source
    USFDA