BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    PMA: P000013 · Decision Feb 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
    Trade Name
    TRIDENT SYSTEM
    PMA Number
    P000013
    Device Class
    FDA Class 3
    Product Code
    MRA
    Generic Name
    Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 3, 2003
    Date Received
    March 2, 2000
    Expedited Review
    N
    Docket Number
    03M-0337

    Advisory Committee Statement

    APPROVAL FOR THE OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM. THESE DEVICES ARE INDICATED FOR PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO PAINFUL DISABLING JOINT DISEASE OF THE HIP RESULTING FROM NON-INFLAMMATORY DEGENERATIVE ARTHRITIS (OSTEOARTHRITIS, AVASCULAR NECROSIS, TRAUMATIC ARTHRITIS, SLIPPED CAPITAL EPIPHYSIS, PELVIC FRACTURE, FEMORAL FRACTURE, FAILED FRACTURE FIXATION, OR DIASTROPHIC VARIANT).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented