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510(k) Data Aggregation

    K Number
    K230226
    Device Name
    Integrity-SI® Fusion System
    Manufacturer
    OsteoCentric Technologies
    Date Cleared
    2023-09-21

    (237 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K161755,K210754,K222512,K211290,K021932,K231951
    Why did this record match?
    Reference Devices :

    K161755, K210754

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

    The Integrity-SI® Fusion System is intended for sacroiliac joint fusion for the following conditions:

    • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
    • To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
    • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
    Device Description

    The Integrity-SI® Fusion System consists of partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 8 mm, 10 mm, and 12 mm diameter screws are offered in partially and fully threaded version in lengths from 40 - 1 10 mm, in 2.5 mm increments and are available in non-coated or hydroxyapatite-coated (HA) versions. The screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5 mm diameter, optional, secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5 mm increments and are only intended for use in conjunction with a primary 8 mm, 10 mm, or 12 mm screw.
    The screws are provided in sterile and non-sterile options.

    AI/ML Overview

    The provided FDA 510(k) clearance letter and summary for the Integrity-SI® Fusion System does not contain information related to an AI-powered medical device or software.

    The device described is a mechanical implant system for sacroiliac joint fusion, consisting of screws and instruments. The performance data presented refers to mechanical testing of the implant's physical properties (torsional properties, driving/removal torque, axial pullout) against an ASTM standard (ASTM F543-17).

    Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study proving an AI device's performance, as the provided text doesn't describe an AI device.

    To answer your request, you would need to provide an FDA clearance document or similar report for an AI-powered medical device.

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