BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Ankle, Uncemented, Non-Constrained

    PMA: P050050 · Decision May 27, 2009
    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 REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
    PMA Number
    P050050
    Device Class
    FDA Class 3
    Product Code
    NTG
    Generic Name
    Prosthesis, ankle, uncemented, non-constrained
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 27, 2009
    Date Received
    December 7, 2005
    Expedited Review
    Y
    Docket Number
    11M-0323

    Advisory Committee Statement

    APPROVAL FOR THE STAR ANKLE. THE DEVICE IS INDICATED FOR USE AS A NON-CEMENTED IMPLANT TO REPLACE A PAINFUL ARTHRITIC ANKLE JOINT DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS OR RHEUMATOID ARTHRITIS.

    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