BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P040033 · Supplement: S039 · Decision Jan 10, 2025
    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
    Supplement Number
    S039
    Device Class
    FDA Class 3
    Product Code
    NXT
    Generic Name
    Prosthesis, hip, semi-constrained, metal/metal, resurfacing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 10, 2025
    Date Received
    December 12, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change in packaging to add alternative top foam inserts used in the packaging of specified sizes of BIRMINGHAM HIP RESURFACING (BHR) Acetabular Cups and BHR Femoral Head Implants manufactured at Smith & Nephew Orthopaedics Ltd. (SNOL), Leamington Spa, United Kingdom

    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