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510(k) Data Aggregation

    K Number
    K012377
    Device Name
    OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
    Manufacturer
    CORIN U.S.A.
    Date Cleared
    2002-03-11

    (228 days)

    Product Code
    HSD,KWS
    Regulation Number
    888.3690
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K992119
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:

    • osteoarthritis .
    • rheumatoid arthritis .
    • revision cases where other devices or treatments have failed .
    • correction of functional deformity .
    • treatment of acute fracture of the humeral head unmanageable using other treatment . methods
    • cuff tear arthroplasty t

    Hemi-resurfacing is also indicated for:

    • humeral head fractures ●
    • avascular necrosis of the femoral head .
    Device Description

    The Oxford Modular Shoulder is a modular total shoulder replacement comprised of 3 components: humeral stem, modular head and glenoid.

    The humeral stem and head are made from cobalt-chrome alloy; the glenoid component is made from ultra high molecular weight polyethylene (UHMWPE). The humeral stem has a proximal one-third plasma sprayed coating to provide fixation and a proximal fin with holes to allow for reconstruction of fractures.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (Oxford Modular Shoulder Prosthesis), not a study evaluating an AI device. As such, the provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is concerned with demonstrating substantial equivalence to a predicate device based on manufacturing materials, design features, and indications for use, supported by mechanical testing of component materials.

    Therefore, I cannot provide the requested information.

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