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

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

    PMA: P010001 · Supplement: S023 · Decision Jun 30, 2021
    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
    Transcend Hip Articulation System
    PMA Number
    P010001
    Supplement Number
    S023
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 30, 2021
    Date Received
    June 7, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The firm identified a process optimization with its new HIP equipment (APG 3076-03 ). The intent of the process optimization (i.e., slight increase of the SR-T limits) in the HIP-sintering step is to ensure a better process capability as well as improved ceramic material and product properties.

    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