BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P830055 · Supplement: S176 · Decision Dec 13, 2016
    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
    ATTUNE TOTAL KNEE SYSTEM
    PMA Number
    P830055
    Supplement Number
    S176
    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 13, 2016
    Date Received
    September 12, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a labeling update to the ATTUNE Knee System Intuition Instruments Surgical Technique. This update to the Surgical Technique labeling contains information for the use of the Rotating Platform (RP) Solid Tibial Insert Trial instruments (Appendix 4) and for the ATTUNE Fixed Bearing system, which references the use of the ATTUNE Revision Fixed Bearing Tibial Base and ATTUNE Revision Cemented Stem cleared in K160700 (Appendix 5).

    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