BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P040048 · Decision Jun 28, 2006
    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
    TRILOGY AB ACETABULAR SYSTEM
    PMA Number
    P040048
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 28, 2006
    Date Received
    December 14, 2004
    Expedited Review
    N
    Docket Number
    07M-0259

    Advisory Committee Statement

    APPROVAL FOR THE TRILOGY AB ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR EITHER CEMENTED OR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY SURGERY FOR REHABILITATING HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.

    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