BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    PMA: P040023 · Supplement: S003 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
    Trade Name
    DURALOC OPTION CERAMIC-ON-CERAMIC HIP SYSTEM
    PMA Number
    P040023
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MRA
    Generic Name
    Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 22, 2005
    Date Received
    November 21, 2005
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE LABELING THAT INCLUDE: 1) THE ADDITION OF AN INTRAOPERATIVE PRECAUTION ADVISING THE SURGEON OF THE NECESSITY FOR CORRECT POSITIONING OF THE INSERT COMPONENT PRIOR TO ASSEMBLING IT TO THE METAL OUTER SHELL AND EXAMINING THE CERAMIC LINER FOLLOWING FINAL ASSEMBLY, AND 2) UPDATING THE ADVERSE EVENT TABLE TO REFLECT THE HIGHER RATE OF INTRAOPERATIVE CHIPPING EXPERIENCED IN THE FIRST SIX MONTHS OF U.S. DISTRIBUTION.

    Classifications

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

    Product Code Device Name
    MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented