BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    PMA: P830055 · Supplement: S081 · Decision Feb 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
    Trade Name
    LCS TOTAL KNEE SYSTEM
    PMA Number
    P830055
    Supplement Number
    S081
    Device Class
    FDA Class 3
    Product Code
    NJL
    Generic Name
    Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 5, 2002
    Date Received
    November 6, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ALLOWING THE MBT REVISION TIBIAL TRAY AND TRAY COMPONENTS, E.G., AUGMENTS, STEM EXTENSIONS, TIBIAL SLEEVES, AND WEDGES, TO BE USED WITH THE ORTHOGENESIS LPS TIBIAL HINGE BEARINGS THAT WERE CLEARED IN K011810.

    Classifications

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

    Product Code Device Name
    NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing