BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P960054 · Supplement: S002 · Decision Dec 7, 1999
    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 ACETABULAR LINER
    PMA Number
    P960054
    Supplement Number
    S002
    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
    Decision Code
    APPR
    Decision Date
    December 7, 1999
    Date Received
    July 30, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design modification made to the S-ROM constrained liner so to be used withthe DePuy Duraloc and Solution Acetabular Cup Systems. 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