BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

    PMA: P910016 · Supplement: S008 · Decision Jan 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
    Trade Name
    NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
    PMA Number
    P910016
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    MBD
    Generic Name
    PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 29, 1997
    Date Received
    December 23, 1996
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SIX SIZE OPTIONS, TWO FIXATION PEGS ON THE FEMORAL COMPONENT, A 7 DEGREE DISTAL BONE CUT SURFACE ON THE FEMORAL COMPONENT, AND A SINGLE MENISCAL BEARING TRACK ACROSS ALL SIZES OF THE TIBIAL COMPONENT FOR THE SECOND GENERATION OF TH E NEW JERSEY LCS TOTAL KNEE SYSTEM UNICOMPARTMENTAL DEVICE CONFIGURATION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBD Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer