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

    Prosthesis, Ankle, Uncemented, Non-Constrained

    PMA: P050050 · Supplement: S016 · Decision Jan 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Prosthesis, Ankle, Uncemented, Non-Constrained
    Trade Name
    Scandinavian Total Ankle Replacment (STAR Ankle)
    PMA Number
    P050050
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    NTG
    Generic Name
    Prosthesis, ankle, uncemented, non-constrained
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 13, 2021
    Date Received
    December 14, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Replace a broken coordinate measuring machine (CMM) used in the production of the STAR Tibial, Talar, and UHMWPE Mobile Bearing (also referred to as the Sliding Cores) components with another CMM (Zeiss Contura CMM) at the Waldemar Link contract manufacturing facility in Germany.

    Classifications

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

    Product Code Device Name
    NTG Prosthesis, Ankle, Uncemented, Non-Constrained