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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: MBI FDA class 2

    Fastener, Fixation, Nondegradable, Soft Tissue

    Orthopedic

    View full classification →

    The nondegradable soft tissue fixation fastener is a permanent orthopedic implant used to anchor soft tissue structures such as ligaments or tendons to bone, remaining in place indefinitely after implantation. It is classified as FDA Class II under 21 CFR 888.3040 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBI and it carries an implant flag. Full GMP quality system requirements apply and it does not sustain life.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Dione PEEK Screw System
    Y-Knotless™ Flex Anchors
    Anchor with Fiber Wire and Disposable Inserter
    ArthroTAK Tendon Anchor Kit
    Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
    Arthrex FiberTak Suture Anchor
    Grappler Suture Anchor PCFD Tether System
    SINEFIX
    Trax EX Anchor
    Strut Suture; No-Tie Button
    FiberTape Button
    TeKBrace Knotless Anchor
    Aevumed FENIX Suture Anchor
    Arthrex Nano FiberTak Suture Anchor
    LigaMend
    Y-Knotless™ Flex Anchors
    Aevumed PROTEKT Suture Anchor
    QuadLock™ Fixation System
    Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
    Tigon Medical Knotless and Dual Javelin All-Suture Anchors
    GMReis Suture Anchors
    Arthrex SutureTak Suture Anchor
    Aevumed FASE Suture Anchor
    Mini Superhawk Suture Anchor System
    All-Suture Dual Anchor System
    Aevumed PHANTOM Suture Anchors
    Iconix Speed Anchor; Iconix Speed HA+ Anchor
    OTS 25-L (100-5)
    Arthrex FiberTak Suture Anchor
    Arthrex PushLock Suture Anchors
    SnugFit ASA Extension
    BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
    CONMED Argo Knotless® Anchor
    PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop
    Shoulder Soft Tissue Anchors
    Arthrex FiberTak Suture Anchor
    RootMend MRR
    Arthrex TightRope Soft Button, RT
    WasherCap™ Fixation System
    SuperBall-RC™
    Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
    WasherCap™ Mini Fixation System (Model 45)
    Osprey Suture Anchor
    Argo Knotless GENESYS Anchor
    OTS 25-L (100-5)
    Tigon Medical All-Suture Anchors (ASA)
    Fix2Lock (PEEK Self Punching)
    OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct
    Iconix Knotless Anchor
    OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft 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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