BEUDAMED
    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: MAI FDA class 2

    Fastener, Fixation, Biodegradable, Soft Tissue

    Orthopedic

    View full classification →

    The biodegradable soft tissue fixation fastener is a surgically implanted orthopedic device used to anchor soft tissue, such as tendons and ligaments, to bone during reconstructive procedures. It is classified as FDA Class II under regulation 21 CFR 888.3030, requiring 510(k) premarket clearance to demonstrate substantial equivalence to a legally marketed predicate device. The product code is MAI and it falls within the Orthopedic medical specialty. As an implanted device it carries an implant flag, and full GMP quality system requirements apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    OSSIOfiber® Suture Anchor
    Knotilus+ Biocomposite Knotless Anchor
    Stryker AlphaVent™ Knotless SP Biocomposite Anchor
    OSSIOfiber® Suture Anchor 2.5-3.5 mm
    Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
    GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor
    Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
    HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
    BIOCHARGE
    Arthrex AlloSync PushLock Suture Anchor
    SF Push- in Anchor
    MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
    Argo Knotless GENESYS Anchor
    X-Twist Biocomposite Suture Anchor
    ecoFIX®
    Rotium Bioresorbable Wick
    Fixone Biocomposite Anchor
    Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
    EUROSCREW NG; EUROSCREW TCP NG
    Arthrex 3.9 mm SwiveLock Anchor
    Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants
    Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
    Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
    Arthrex Self Punching SwiveLock Suture Anchors
    Arthrex Self-Punching PushLock Suture Anchor
    Bioabsorbable Anchor
    OSSIOfiber Suture Anchor
    Fixone hybrid knotless anchor
    OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
    Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
    Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
    Arthrex SwiveLock Anchor
    CITRESPLINE and CITRELOCK ACL Implants
    MectaLock Extension
    The Citrefix Knotless Suture Anchor
    Arthrex FastThread Interference Screw
    Citregen Tendon Interference Screw and Citrelock
    Arthrex SwiveLock Anchor
    Arthrex Mini Hip PushLock
    Rotium Bioresorbable Wick
    HEALICOIL Knotless Suture Anchors
    Fixone Biocomposite Anchor
    Fixone Biocomposite Small Anchor
    Arthrex SwiveLock Suture Anchor
    Arthrex 3.9mm Corkscrew Suture Anchor
    Parcus Knotless AP Suture Anchors
    Arthrex SwiveLock Anchor
    Arthrex SwiveLock Anchors
    HEALIX ADVANCE SP BIOCOMPOSITE Anchor
    Arthrex SwiveLock Suture Anchor

    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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