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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
    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
    Extremity All Suture System
    VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)
    Fixone Meniscal Repair
    Grappler Interference Screw System
    Suture Button Repair System
    Iconix® Anchor
    Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue
    Arthrex TightRope II
    Megaloop Button System
    OC JuggerKnot Soft Anchor
    Grappler Suture Anchor R3FLEX IOL System
    ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor
    Iconix Knotless Anchor
    ProCinch, QuadCinch
    AlphaVent Knotless SP PEEK Anchor
    Footprint Mini PK, 3.5mm Suture Anchor
    CEPTRE® Knotted UHMWPE Suture PEEK Anchor
    SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
    Suture Wing
    OTS 25 (100-1)
    IDEAL Ziploop
    Arthrex Knee FiberTak® Button Suture Anchor
    Iconix Anchor
    INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
    Arthrex FiberTak Suture Anchor
    Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
    Knotilus+ PEEK Knotless Anchor
    Shadow Knotless All-Suture Anchors
    JuggerKnot Soft Anchor OC

    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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