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510(k) Data Aggregation

    K Number
    K092122
    Date Cleared
    2009-07-27

    (13 days)

    Product Code
    Regulation Number
    888.3660
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The StepTech™ Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

    1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
    2. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
    3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
      Glenoid components are intended for cemented use only.
    Device Description

    The DePuy Global Shoulder StepTech Anchor Peg Glenoid is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from crosslinked polyethylene conforming to ASTM F648, and is offered in sizes 40, 44, 48, 52 and 56 (bearing diameter and outside profile size) with step heights of +3, +5 and +7 (size of posterior buildup).

    AI/ML Overview

    This document describes a medical device, the DePuy Global Shoulder StepTech Anchor Peg Glenoid, and its substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria, the results of a study proving the device meets those criteria, or any of the other specific study-related details typically found in a clinical trial report or a performance validation study.

    Therefore, I cannot provide the requested information based on the input text. The provided text is a 510(k) summary for a medical device seeking clearance based on substantial equivalence, not a performance study report.

    In summary, the input document does not include the information necessary to fulfill the request concerning acceptance criteria and a study proving device performance.

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