BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    PMA: P190009 · Supplement: S006 · Decision Nov 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
    Trade Name
    OPRA Implant System, Abutment component
    PMA Number
    P190009
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    PJY
    Generic Name
    Osseoanchored prostheses for the rehabilitation of transfemoral amputees
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 20, 2025
    Date Received
    September 27, 2024
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval of an addition of a Low Plasticity Burnishing (LPB) step in the manufacturing process of the Abutment component of the OPRA device.

    Classifications

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

    Product Code Device Name
    PJY Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees