BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000013 · Supplement: S010 · Decision Jan 18, 2012
    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
    TRIDENT SYSTEMS
    PMA Number
    P000013
    Supplement Number
    S010
    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
    January 18, 2012
    Date Received
    October 3, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE TRITANIUM PSF ACETABULAR SHELLS (SOLID-BACKED AND CLUSTER SCREW-HOLE DESIGNS) AS COMPATIBLE COMPONENTS WITH THE TRIDENT CERAMIC INSERTS, AS WELL AS MODIFICATIONS TO THE TOLERANCES AND SURFACE ROUGHNESS VALUES OF THE TAPER REGION OF ALL COMPATIBLE TRIDENT AND TRITANIUM ACETABULAR SHELLS. IN ADDITION, LABELING CHANGES WERE MADE TO ADDRESS THE COMPATIBILITY WITH THE NEW COMPONENTS.

    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