BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

    PMA: P960054 · Decision Jun 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155

    Basic Information

    Device Name
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
    Trade Name
    S-ROM POLY-DIAL CONSTRAINED LINER
    PMA Number
    P960054
    Device Class
    FDA Class 2
    Product Code
    KWZ
    Generic Name
    Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
    Regulation Number
    888.3310
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    June 19, 1997
    Date Received
    December 26, 1996
    Expedited Review
    N
    Docket Number
    97M-0416

    Advisory Committee Statement

    APPROVAL FOR THE JOHNSON AND JOHNSON'S S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER. THIS DEVICE IS INDICATED FOR USE AS A COMPONENT OF A TOTAL HIP PROSTHESIS IN PRIMARY OR REVISION PATIENTS AT HIGH RISK OF HIP DISLOCATION DUE TO A HISTORY OF PRIOR DISLOCATION, BONE LOSS, JOINT OR SOFT TISSUE LAXITY, NEUROMUSCULAR DISEASE OR INTRAOPERATIVE INSTABILITY.

    Classifications

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

    Product Code Device Name
    KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer