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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: HTN FDA class 2

    Washer, Bolt Nut

    Orthopedic

    View full classification →

    A bolt nut washer is a small metal orthopedic hardware component used in conjunction with bone screws and bolts to secure internal fixation implants during bone fracture repair or spinal stabilization. It is classified as an FDA Class 2 device under 21 CFR 888.3030, indicating moderate risk and requiring 510(k) premarket clearance. Product code HTN falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LARS ACJ
    SportLinc Syndesmosis Device
    Syndesmosis TightRope PRO
    Synchfix EVT
    RipCord
    Acu-Sinch Knotless Mini
    Bolo Button System
    TACTIX Vector Syndesmosis System
    EXPERT - Flexible Joint Fixation System
    TACTIX Vector Syndesmosis System
    TENSOR® Suture Button System
    OIC FLEX-FIX™ System
    CC-Clip® Implant System
    Arthrex FiberTape and TigerTape Cerclage Sutures
    Arthrex FiberTape and TigerTape Cerclage Sutures
    Arthrex Knotless AC Repair Devices
    TriMed Ripcord Device
    Hercules Syndesmosis Implant System
    Acumed Ankle Syndesmosis Repair System
    Arthrex Knotless Mini TightRopes
    Medline UNITE REFLEX Dynamic Discs
    EXPERT - Joint Fixation System
    Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
    Akros Scruture Anchor LisFranc Repair Kit
    LARS AC Band Device
    MicroLink All-Suture Button Fixation System (Radiolucent)
    MicroLink All-Suture Button Fixation System (Radiopaque)
    CyclaPlex Correction System
    Double ENDOBUTTON Fixation Device
    Infinity-Lock Button System
    PUMA System
    Akros FibuLink™ Syndesmosis Repair Kit
    SyndesMetrics Syndesmosis Repair System
    GRAVITY™ Syndesmosis LP
    INVISIKNOT Ankle Syndesmosis Repair Kit
    KISSloc Suture System
    Akros Fibulink Syndesmosis Repair Kit
    M-Fix Acromioclavicular Device
    Tensyn Plug
    Tensyn Plug
    FASTFORWARD
    TENSYN BAND, TENSYN FRACTURE PLATES
    JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
    ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
    CMC MINI TIGHTROPE
    TENSYN BAND
    MINI TIGHTROPE
    ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
    TENSYN BAND
    BIOPRO - INFINITY PLATE ANCHOR 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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