BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    PMA: P040033 · Decision May 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
    Trade Name
    BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
    PMA Number
    P040033
    Device Class
    FDA Class 3
    Product Code
    NXT
    Generic Name
    Prosthesis, hip, semi-constrained, metal/metal, resurfacing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2006
    Date Received
    July 19, 2004
    Expedited Review
    Y
    Docket Number
    06M-0193

    Advisory Committee Statement

    APPROVAL FOR THE BIRMINGHAM HIP RESURFACING (BHR) SYSTEM. THE BHR SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT. THE HGR SYSTEM IS INTENDED FOR USE IN PATIENTS REQUIRING PRIMARY HIP RESURFACING ARTHROPLASTY DUE TO: 1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS, OR DYSPLASIA/DEVELOPMENTAL DISLOCATION OF THE HIP (DDH), OR 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS. THE BHR SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING FUTURE IPSILATERAL HIP JOINT REVISION.

    Classifications

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

    Product Code Device Name
    NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing