BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P830055 · Supplement: S157 · Decision Jun 5, 2015
    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
    S157
    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
    June 5, 2015
    Date Received
    March 23, 2015
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF ATTUNE CEMENTLESS CRUCIATE RETAINING(CR) AND POSTERIOR STABILIZED (PS) FEMORAL COMPONENTS AS COMPATIBLE COMPONENTS WITH THEAPPROVED ATTUNE CR AND PS ROTATING PLATFORM (RP) TIBIAL INSERTS AND ATTUNE RP (CEMENTED) TIBIAL BASES. INCLUDING STERILE SINGLE USE INSTRUMENTATION, TO BE USED WITH THE APPROVED ATTUNE RP 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