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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OUR FDA class 2

    Sacroiliac Joint Fixation

    Orthopedic

    View full classification →

    The Sacroiliac Joint Fixation device (product code OUR) is an implantable orthopedic system used for sacroiliac joint fusion, indicated for patients with sacroiliac joint dysfunction causing chronic lower back or pelvic pain. It stabilizes the sacroiliac joint to promote bony fusion and pain relief. As an FDA Class 2 device under regulation 888.3040, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. The device is flagged as an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    panaSIa SI Fusion System
    The Rialto™ SI Fusion System
    Omnia Medical PsiF DNA™ System
    SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
    Patriot SI Implant System
    DYNAMIS™ Implant System
    Catamaran SI Joint Fusion System
    NEXXT MATRIXX® SI System
    DYNAMIS™ SI Screw System
    TiLink-P SI Joint Fusion System
    TiLink-P Joint Fusion System
    TiLink-P SI Joint Fusion System
    iFuse TORQ TNT™ Implant System
    SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
    ARx® SAI Implant System
    iFuse TORQ® Implant System
    Eminent Spine SI Screw System
    BowTie™ SI Joint Fusion System
    Patriot-SI Posterior Implant System
    TiLink-P SI Joint Fusion System
    Camber Sacroiliac (SI) Fixation System
    PathLoc SI Joint Fusion System
    iFuse Bedrock Granite® Implant System
    TORPEDO Implant System®
    Liberty SI Lateral Implant System
    SOLACE Sacroiliac Fixation System
    REUNION Sacroiliac Joint Fusion System
    TransLoc 3D
    Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
    TiLink-P SI Joint Fusion System
    Integrity-SI® Fusion System
    CATAMARAN SI Joint Fusion System
    Xenix Medical Sacroiliac Fixation System
    TiLink-L Joint Fusion System
    SI-Cure Sacroiliac Joint Fusion System
    PathLoc SI Joint Fusion System
    iFuse TORQ® Implant System
    TiLink-L SI Joint Fusion System
    Kisar Stratford SI Screw System
    T-FIX™ 3DSI Joint Fusion System
    SiJoin®T3
    Entasis 3D Dual-Lead Sacroiliac Implant System
    ZESPIN SI Joint Fusion System
    SI-Cure Sacroiliac Joint Fusion System
    iFuse Bedrock Granite® Implant System
    CASSATT™ SIJ Fixation System
    UNITY Sacroiliac Joint Fixation System
    SILO TFX MIS Sacroiliac Joint Fixation System
    iFuse TORQ® Implant System
    Integrity-SI Fusion System

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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