BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070026 · Supplement: S004 · Decision Apr 2, 2013
    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
    DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
    PMA Number
    P070026
    Supplement Number
    S004
    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
    April 2, 2013
    Date Received
    November 1, 2011
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    13M-0462

    Advisory Committee Statement

    APPROVAL FOR DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM. THIS DEVICE IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEMENT SURGERY FOR REHABILITATIONOF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST-TRAUMATIC ARTHRITIS.

    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