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510(k) Data Aggregation

    K Number
    K123122
    Device Name
    GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
    Manufacturer
    CLEVELAND CLINIC
    Date Cleared
    2013-04-05

    (183 days)

    Product Code
    KWS
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEVELAND CLINIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Anchor Peg Glenoid (APG) component of the DePuy AP Shoulder System, the DePuy Global StepTech Glenoid component, or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The Glenoid IRIS is not indicated for use in hemi-shoulder arthroplasty. The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.
    Device Description
    The Glenoid Intelligent Reusable Instrument System is composed of two (2) manual instruments intended for use to facilitate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. CT data and 3D modeling is used to provide preoperative planning of total shoulder glenoid component or reverse shoulder metaglene component orientation according to each patient's glenoid anatomy. The preoperatively planned and surgeon approved component orientation is subsequently transferred to the patient's glenoid during surgery by the use of a patient specific instrument and an adjustable instrument with patient specific settings. A patient specific Glenoid SmartBone - Pin Trajectory instrument is used to set the adjustable reusable instrument, the Glenoid Intelligent Reusable Instrument (Glenoid IRI), with the settings necessary to reflect the guide pin trajectory embedded in the Glenoid SmartBone. The Glenoid IRI is then used to guide the placement of the standard 2.5 mm pin (Steinmann pin) by the surgeon that is used in preparation of the glenoid for implantation of the glenoid component. All other steps of the surgical procedure are accomplished according to each system's standard surgical technique.
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