BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    PMA: P010014 · Supplement: S111 · Decision Aug 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
    Trade Name
    Oxford™ Knee System
    PMA Number
    P010014
    Supplement Number
    S111
    Device Class
    FDA Class 3
    Product Code
    NRA
    Generic Name
    Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 7, 2025
    Date Received
    July 29, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    reduction of Nitric biological upgrade cycle time within the nitric immersion tanks and the heated immersion rinse tanks from 600 seconds to 300 seconds, and use of an additional Biological Upgrade Line for Nitric Biological Upgrade process at the Zimmer Orthopedics Manufacturing Limited, Shannon, Ireland facility

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing