BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P910016 · Supplement: S012 · Decision Feb 4, 2002
    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
    LCS UNI TOTAL KNEE SYSTEM
    PMA Number
    P910016
    Supplement Number
    S012
    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
    February 4, 2002
    Date Received
    December 12, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE TIBIAL TRAY AND TIBIAL BEARING COMPONENTS OF THE LCS UNI TOTAL KNEE SYSTEM. THESE MODIFICATIONS INCLUDE: A CHANGE TO THE PROXIMAL ARTICULATING SURFACE OF THE TIBIAL BEARING IN ORDER TO ACCOMMODATE IT'S USE WITH THE PRESERVATION UNI FEMORAL COMPONENT; A CHANGE IN POLYETHYLENE RAW MATERIAL; A 1 MM REDUCTION IN THE DOVETAIL HEIGHT OF THE POLYETHYLENE BEARING; REFINING THE OUTER PROFILE OF THE TIBIAL TRAY TO BE LEFT/RIGHT SPECIFIC AND TO OPTIMIZE THE TIBIAL BONE COVERAGE; CEMENTED USE ONLY; REPLACING THE POROUS COATING ON THE TIBIAL TRAY WITH A GRIT-BLAST SURFACE FINISH; AND, REPLACING THE FIXATION PEG WITH A FIXATION KEEL. THE DEVICE COMPONENTS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRESERVATION UNI MOBILE BEARING KNEE SYSTEM, AND ARE INDICATED FOR CEMENTED USE IN PATIENTS OVER 60 YEARS OLD UNDERGOING UNICOMPARTMENTAL KNEE SURGERY FOR REHABILITATING KNEES WHEN ONLY ONE CONDYLE HAS BEEN DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS OR POST-TRAUMATIC ARTHRITIS.

    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