BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000013 · Supplement: S009 · Decision May 7, 2009
    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
    OSTEONICS ABC/TRIDENT SYSTEMS
    PMA Number
    P000013
    Supplement Number
    S009
    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
    May 7, 2009
    Date Received
    April 16, 2009
    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 (I.E., SURGICAL PROTOCOL) OF THE TRIDENT HIP SYSTEM. THESE MODIFICATIONS INCLUDE CREATING SEPARATE AND DISTINCT SURGICAL PROTOCOLS, ONE FOR THE TRIDENT PSL SHELL AND ONE FOR THE TRIDENT HEMISPHERICAL SHELL, IN ORDER TO CLARIFY THE DIFFERENCES IN REAMING TECHNIQUES BETWEEN THE TWO SHELLS, AS WELL AS OTHER IMPROVEMENTS TO THE SURGICAL PROTOCOL.

    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