BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000013 · Supplement: S001 · Decision Mar 17, 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
    OSTEONICS ABC/TRIDENT SYSTEMS
    PMA Number
    P000013
    Supplement Number
    S001
    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
    March 17, 2003
    Date Received
    February 4, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING ITEMS: 1) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40 ALUMINA HEADS AND ADDITIONAL C-TAPER ALUMINA HEAD SIZES (AND ASSOCIATED STEMS) 2) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40/C-TAPER AND MORSE TAPER ADAPTER SLEEVES (AND ASSOCIATED FEMORAL STEMS) 3) USE OF ADDITIONAL STYLES OF TRIDENT ACETABULAR SHELLS; AND 4) ASSOCIATED LABELING CHANGES DUE TO MODIFICATIONS IDENTIFIED ABOVE.

    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