BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010014 · Supplement: S021 · Decision Aug 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
    Trade Name
    OXFORD PARTIAL KNEE
    PMA Number
    P010014
    Supplement Number
    S021
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 15, 2008
    Date Received
    June 18, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF COMPUTER AIDED SURGERY (CAS) NAVIGATION SURGICAL INSTRUMENTS FOR USE WITH THE BRAINLAB UNI-KNEE IMAGE GUIDANCE SYSTEM FOR USE WITH THE OXFORD PARTIAL KNEE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OXFORD PARTIAL KNEE SYSTEM AND IS INTENDED FOR USE IN INDIVIDUALS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND IS INTENDED TO BE IMPLANTED WITH BONE CEMENT.

    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