BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    PMA: P190009 · Decision Dec 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
    Trade Name
    OPRA Implant System
    PMA Number
    P190009
    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
    December 18, 2020
    Date Received
    April 5, 2019
    Expedited Review
    N
    Docket Number
    20M-2324

    Advisory Committee Statement

    Approval for the OPRA Implant System. The device is indicated for patients who have transfemoral amputation due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA Implant System is intended for skeletally mature patients.The patient failed to receive benefit from socket prostheses or is expected to not tolerate socket use due to problems such as:1) Recurrent skin infections and ulcerations in the socket contact area;2) Pain;3) A short stump preventing the use of socket prosthesis;4) Volume fluctuation in the stump;5) Soft tissue scarring;6) Extensive area of skin grafting;7) Socket retention problems due to excessive perspiration; and8) Restricted mobility.

    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