BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P830055 · Supplement: S136 · Decision Aug 28, 2013
    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
    LCS TOTAL KNEE SYSTEM
    PMA Number
    P830055
    Supplement Number
    S136
    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
    August 28, 2013
    Date Received
    July 29, 2013
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF INSPECTIONS TO CHECK THE PROFILE OF THE DISTAL CONDYLES AS WELL AS THE MEDIAL-LATERAL (M/L) WIDTH AND TRUE POSITION OF THE SIGMA CR150 SIZE 5 & 6 FEMORAL COMPONENTS DURING THE MANUFACTURING PROCESS. THE SIGMA CR150 FEMORAL COMPONENTS WERE PREVIOUSLY APPROVED AS COMPATIBLE COMPONENTS TO THE PRIMARY CURVED RP BEARING INSERTS AND MBT TIBIAL TRAYS.

    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