BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060037 · Supplement: S005 · Decision Mar 26, 2009
    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 COMPLETE KNEE SOLUTION
    PMA Number
    P060037
    Supplement Number
    S005
    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
    March 26, 2009
    Date Received
    September 29, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT,RESULTING IN THE NEXGEN MINIMALLY INVASIVE SOLUTIONS (MIS) LPS-MOBILE TIBIAL COMPONENT.CHANGES MADE TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT INCLUDE SHORTENING THETIBIAL BASEPLATE STEM AND ADDING BROAD PROXIMAL FINS, CHANGING THE OUTER PROFILE RADIUS OF THEBASEPLATE EDGE FROM A VARIABLE RADIUS TO A CONSTANT RADIUS, AND ADDING AN ADDITIONAL SIZE (4-PLUS)TO THE CURRENT RANGE OF SIZES (1 - 8).

    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