BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P830055 · Supplement: S112 · Decision Dec 8, 2009
    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 ¿ P.F.C. SIGMA RPF FEMORAL COMPONENTS
    PMA Number
    P830055
    Supplement Number
    S112
    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
    December 8, 2009
    Date Received
    October 6, 2009
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL IN-PROCESS DIMENSIONAL INSPECTIONS OF THE P.F.C. SIGMA RPF FEMORAL COMPONENTS.

    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