BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030022 · Supplement: S008 · Decision Feb 18, 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
    REFLECTION CERAMIC ACETABULAR SYSTEM
    PMA Number
    P030022
    Supplement Number
    S008
    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
    February 18, 2009
    Date Received
    October 2, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) THE ADDITION OF THE REFLECTION 3 (R3) CERAMIC (BIOLOX FORTE) LINERS (32MM ID, 36MM ID), WHICH FEATURE A FACTORY-ASSEMBLED TITANIUM ALLOY OUTER RING; THE MODIFIED ACETABULAR SHELL(I.E., R3 ACETABULAR SHELLS) TO ACCEPT THE MODIFIED CERAMIC LINERS; AND THE 36MM BIOLOX FORTE FEMORAL HEAD (+0, +4. +8); 2) AN ADDITIONAL MANUFACTURING SITE AT SMITH & NEPHEW ORTHOPAEDICS, TUTTLINGEN, GERMANY, FOR THEMANUFACTURING AND ASSEMBLY OF THE TITANIUM RING; AND 3) A STERILIZATION SITE FOR THE R3 CERAMIC LINERS WITH THE AFFIXED OUTER METAL RING AT BBF STERILIZATION SERVICES, GMBH, KERNEN, GERMANY.

    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