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510(k) Data Aggregation

    K Number
    K232878
    Device Name
    TransLoc 3D
    Manufacturer
    Foundation Fusion Solutions, LLC (dba CornerLoc)
    Date Cleared
    2023-10-17

    (29 days)

    Product Code
    OUR,CLA,HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K223819,K222512,K021932,K211496
    Why did this record match?
    Reference Devices :

    K223819, K222512, K021932

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

    The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including:

    · 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.

    The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

    Device Description

    TransLoc 3D implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as a Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone and may be used in the same procedure with CornerLoc bone graft. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint. All implants are provided sterile packaged for single use. Non-sterile instruments are available to assist with the surgical procedure and must be sterilized prior to use.

    AI/ML Overview

    I am sorry, but the provided text focuses on the regulatory clearance (510(k) submission) of the TransLoc 3D device. It outlines the device's indications for use, its description, and its substantial equivalence to a predicate device based on non-clinical testing and technological characteristics comparison.

    The document does not contain any information regarding acceptance criteria, reported device performance metrics, particulars of a study (like sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or details about training sets.

    Therefore, I cannot provide the requested table and study information based on the given text.

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