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

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

    PMA: P830055 · Supplement: S303 · Decision Feb 1, 2023
    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
    S303
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 1, 2023
    Date Received
    January 11, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change from etching Cobalt Chrome products with Red yttrium aluminum garnet (YAG) Laser using ink to Green Beam Laser without ink at the DePuy Orthopaedics, Inc., Warsaw, IN manufacturing site.

    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