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510(k) Data Aggregation

    K Number
    K984492
    Device Name
    TIGRAN HIP PROSTHESIS
    Manufacturer
    Date Cleared
    1999-03-15

    (88 days)

    Product Code
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    PONMED LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tigran TM Hip Prosthesis for total hip arthoplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The Tigran TM Hip Prosthesis is designed for implantation into the human femur in total or hip replacement and is indicated for the following: 1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur 2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; 3) Patients suffering from disability due to previous fusion; 4) Patients with previously failed endoprostheses and/or total hip components in the affected extremity: 5) Patients with acute femoral neck fractures.
    Device Description
    The Tigran™ Femoral Prosthesis for hip arthroplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The femoral stem is made from Titanium Ti-6A1-4V Alloy, a high fatigue strength material with a long history of clinical use and exceptional The surface of the femoral stem is prepared with a surface finish and biocompatibility. pattern to provide optimal initial and lasting fixation in bone. The femoral stem has a collar and is modular in design, incorporating a Morse-type tapered neck and utilizing modular femoral heads. The Femoral stem is straight and with a rectangular crosssectional shape to provide optimal, rotational stability. The Tigran™ Prosthesis Femoral Stem is available in four neck sizes (short, medium, long and extra long). The femoral head is fabricated from Cobalt-Chromium-Molybdenum Alloy and comes in three neck configurations (short, medium and long) and in one head diameter (28mm). The various neck lengths provided allow this prosthesis to fit different variations found in the human femora. The titanium and chrome-cobalt alloy components can be used together, although they are made from dissimilar alloys. In vitro electrochemical corrosion studies have shown that no detrimental changes occur when the two alloys are coupled. Special instruments are available to assist in mating, disassembling, and the accurate installation of the implant components. The Tigran™ Femoral Prosthesis (femoral stem and head) may be used with any acetabular prosthesis with an articulating surface made of ultra high molecular weight polyethylene (UHMWP) and designed to be used with a 28 mm CoCrMo Alloy femoral head.
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