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510(k) Data Aggregation

    K Number
    K252834

    Validate with FDA (Live)

    Device Name
    Sacroiliac Joint Truss System (SJTS)
    Manufacturer
    4Web Medical
    Date Cleared
    2026-01-28

    (145 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K203065,K222605,K220195
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sacroiliac Joint Truss System is indicated for sacroiliac joint fusion for:

    • Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
    • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

    The Sacroiliac Joint Truss System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

    Device Description

    The SJTS is a comprehensive surgical solution for sacroiliac joint fusion procedures. The system consists of an instrument set and a wide range of threaded implants. All screws in the 4Web SJTS are cannulated, fenestrated, and made of medical grade Ti6Al4V alloy. The screws come in two distinct sterile implant offerings: a fully threaded screw with compression threads on the proximal head and a partially threaded lag screw with an accompanying washer. The implant offering includes a choice of three different diameters with a variety of lengths to accommodate the patient's anatomy.

    The SJTS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

    AI/ML Overview

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