BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010001 · 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
    CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
    PMA Number
    P010001
    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
    January 31, 2001
    Expedited Review
    N
    Docket Number
    03M-0332

    Advisory Committee Statement

    APPROVAL FOR THE CERAMIC TRANSCEND HIP ARTICULATION SYSTEM. THE DEVICE IS INDICATED FOR PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE 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