BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P830055 · Supplement: S330 · Decision Nov 13, 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
    ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Knee System, ATTUNETM Revi
    PMA Number
    P830055
    Supplement Number
    S330
    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
    November 13, 2024
    Date Received
    August 16, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for updating the MRI Safety Labeling for the ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Knee System, ATTUNETM Revision Rotating Platform (RP) Knee System, DePuy P.F.C.TM SigmaTM Rotating Platform (RP) Total Knee System and M.B.T. Revision Knee 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