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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: KTT FDA class 2

    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

    Orthopedic

    View full classification →

    The Multiple Component Nail/Blade/Plate Combination Fixation Appliance is an orthopedic implant system composed of multiple assembled components used to internally fix fractures of the proximal femur and peritrochanteric region, providing structural support during bone healing. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KTT, regulated under 21 CFR 888.3030, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Extremity Medical External Fixation System
    Orthex External Fixation System
    Extremity Medical External Fixation System
    TrueLok Elevate
    Monkey Bars Pin to Bar External Fixation System
    Response Ortho Metaphyseal Hinge Fixator System
    Revolution External Plating System
    LINK(TM) External Fixator
    Hoffmann LRF System
    Auxein's DHS/DCS Plate System
    Arthrex Small External Fixation System
    Monkey RingsTM External Fixation System
    DEPUY SYNTHES MAXFRAME AUTOSTRUT System
    Smart Correction System (HA Half Pins)
    Orthex External Fixation System
    ONX Large External Fixation System
    Smart Correction System Rings and Compatible HA-Coated Half Pins
    Drive Rail System
    Paragon 28 External Ring Fixation System
    TrueLok Evo
    Correx Software
    SMART Taylor Spatial Frame
    MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
    OIC External Fixation System
    Hoffmann LRF System
    Sequel External Fixation Device
    AutoStrut G2
    Bfix Orthopedic External Fixator Systems
    Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
    Circular Fixation with Balanced Cable Transport
    Pitkar DeftFix System
    Accessories for the SixFix® Hexapod Fixator
    Smart Correction System
    FusionFrame Ring Lock System
    Dynex Micro
    Dynex Ring Fixation System, Diametrix Ring Fixation System
    Pitkar External Fixation System - Rail Mechanism
    PRECICE Plating System
    Pitkar External Fixation System
    AutoStrut
    Revolution External Plating System
    SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
    OIC External Fixation System
    Austin Miller Large External Fixation System
    Hoffmann LRF System
    Depuy Synthes Femoral Neck System
    External Fixation System
    Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
    SALVATION External Fixation System
    DePuy Synthes Femoral Neck 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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