BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: N980003 · Decision Nov 26, 2003
    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
    KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
    PMA Number
    N980003
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 26, 2003
    Date Received
    March 8, 1998
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PRODUCT DEVELOPMENT PROTOCOL (PDP) FOR THE KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM. THIS DEVICE IS INDICATED FOR USC IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY FOR THE TREATMENT OF INFLAMMATORY TISSUE DISORDERS AND NONINFLAMMATORY DEGENERATIVE JOINT DISEASE, INCLUDING OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS OR SECONDARY ARTHRITIS, AND AVASCULAR NECROSIS.

    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