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: HTY FDA class 2

    Pin, Fixation, Smooth

    Orthopedic

    View full classification →

    A smooth fixation pin is a thin, smooth metallic implant driven into bone to stabilize fractures, maintain bone alignment, or anchor other fixation hardware during orthopedic procedures. It is classified as an FDA Class 2 device under 21 CFR 888.3040, indicating moderate risk and requiring 510(k) premarket clearance. Product code HTY falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PediFlex™ Flexible Nail System
    Impact PEEK Union Nail System
    Biomet Kirschner Wires (K-Wires)
    OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
    Hammerdesis™ Interphalangeal Fusion System
    OSSIOfiber® Cannulated Trimmable Fixation Nail
    Electro-Spec Steri-Caps
    Tyber Medical Pin and Wire System (various)
    Hammertoe Truss System (HTS)
    SECURE-LOCK
    Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
    restor3d Pin Implants
    Small Bone Nailing System
    CoLink Sfx Implant System
    LimaCorporate Kirschner Wire
    PediFlex Flexible Nail System
    OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
    VeriFixx™ Small Bone Implant
    OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
    Smart Toe II, X Fuse
    Arthrex DynaNite K-Wire
    OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
    Hammertoe Truss System (HTS)
    Arthrex DynaNite® PIP (Hammertoe) Implant
    HammerToe Compression System
    OSSIO™ Pin Product Family
    A.M. Surgical Intramedullary Fixation Device
    HammerTube System
    Footmotion HammerToe
    DIP Arthrodesis System
    WishBone K-Wire System
    Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
    dynaMX Intramedullary Implant
    Stryker SonicPin System
    Precifit Medical Kirschner Wires
    Syntorr K-wire and Pin System
    Additive Orthopaedics Hammertoe Correction System
    StarFuse Interphalangeal Pin
    S-Wire
    In2Bones Kirschner wire
    IFS Fixation Scaffold System
    Bio2 Fusion Implant System
    opti-Toe
    Rush Medullary Pins
    ProCinch Adjustable Loop Device
    Arthrex Blunt Tip Screws with Fiber Tape
    LYNC intramedullary implant
    Kirschner Wires, Steinmann Pins
    Stryker SonicPin System, Stryker SonicAnchor System
    PRO-TOE X-FLEX HAMMERTOE FIXATION 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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump