BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P150030 · Supplement: S036 · Decision Apr 29, 2024
    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
    R3 Delta Ceramic Hip System
    PMA Number
    P150030
    Supplement Number
    S036
    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
    April 29, 2024
    Date Received
    September 11, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of an alternative manufacturing facility (Smith And Nephew Operations Sdn. Bhd PMT 797, Persiaran Cassia Selatan 8 Taman Perindustrian Batu Kawan, Bandar Cassia Penang Pulau Pinang, Malaysia 14110) for R3™ Acetabular Shells which are approved for use as part of the P150030 - R3™ Delta Ceramic Acetabular System as well as an additional vendor for sterilization (Synergy Sterilisation(M) Sdn. Bhd., Plot 203, Kuala Ketil Industrial Estate, Kuala Ketil Kedah, Malaysia 09300).

    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