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

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

    PMA: P830055 · Supplement: S259 · Decision Nov 27, 2020
    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
    S259
    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
    November 27, 2020
    Date Received
    October 28, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Establish the SAFC St. Louis site as an additional supplier of AOX antioxidant solution to ensure continued availability of the AOX bar stock material, which is used in manufacture of the ATTUNE Revision CRS Rotating Platform Inserts, the ATTUNE CR Rotating Platform Inserts, the ATTUNE PS Rotating Platform Inserts, theSigma Rotating Platform AO Curved Tibial Inserts, and the Sigma Rotating Platform AO Stabilized Tibial Inserts at the DePuy Cork site; and of the LCS Complete RPS AOX Inserts, the LCS Complete RP AOX Inserts and the Sigma RPF AOX Inserts at the DePuy Raynham 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