BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050016 · Supplement: S005 · Decision Dec 3, 2009
    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
    Supplement Number
    S005
    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
    December 3, 2009
    Date Received
    November 2, 2009
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND PATIENT BROCHURE TO INCLUDE TWO ADDITIONAL POTENTIAL ADVERSE EFFECTS, PSEUDOTUMOURS AND AVASCULAR LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESIONS (ALVAL) AS WELL AS AN ADDITIONAL PRECAUTION THAT THE SUBJECT DEVICE HAS NOT BEEN TESTED IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.

    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