BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    PMA: P190009 · Supplement: S010 · Decision Mar 12, 2026
    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
    PMA Number
    P190009
    Supplement Number
    S010
    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
    March 12, 2026
    Date Received
    September 26, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    approval for revisions to the device labeling that was updated to include information on the Post-Approval Study (PAS), TFAOS PAS, for the OPRA Implant System

    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