BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060037 · Supplement: S092 · Decision Dec 12, 2024
    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
    NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
    PMA Number
    P060037
    Supplement Number
    S092
    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 12, 2024
    Date Received
    November 19, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    revision of device labeling to implement the following changes: 1) Addition of further information to Package Insert to provide detailed information of Implant material composition, and warning for carcinogenic, mutagenic and reprotoxic (CMR) substance, Intended Purpose, Intended Use, Patient Target Group, Intended Users, Expected Lifetime Statement, Expected Clinical Benefit, Patient Counseling information, and Disclosure of Residual Risks; 2) Information for Patient (IFP) will be created and be accessible to patients via Zimmer Biomet website, and 3) Patient Implant Card label will be provided with a device

    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