BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    PMA: P050016 · Decision Jul 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
    Trade Name
    CORMET HIP RESURFACING SYSTEM
    PMA Number
    P050016
    Device Class
    FDA Class 3
    Product Code
    NXT
    Generic Name
    Prosthesis, hip, semi-constrained, metal/metal, resurfacing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 3, 2007
    Date Received
    March 30, 2005
    Expedited Review
    Y
    Docket Number
    07M-0286

    Advisory Committee Statement

    APPROVAL FOR THE CORMET HIP RESURFACING SYSTEM. THE CORMET HIP RESURFACING SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD AND CEMENTLESS ACETABULAR COMPONENT. THE DEVICE IS INTENDED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS: 1) NON-INFLAMMATORY DEGENERATIVE ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS. THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING IPSILATERAL HIP JOINT REVISION.

    Classifications

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

    Product Code Device Name
    NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing