BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Ankle, Uncemented, Non-Constrained

    PMA: P160036 · Supplement: S004 · Decision Nov 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Prosthesis, Ankle, Uncemented, Non-Constrained
    Trade Name
    Hintermann Series H3 Total Ankle Replacement System
    PMA Number
    P160036
    Supplement Number
    S004
    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
    November 6, 2023
    Date Received
    May 8, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to introduce patient specific instrumentation (i.e., OPTIX Patient Specific Instruments (PSI)) to the Hintermann Series H3 Total Ankle Replacement System.

    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