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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: JEC FDA class 2

    Component, Traction, Invasive

    Orthopedic

    View full classification →

    An Invasive Traction Component is an orthopedic device inserted percutaneously or surgically into bone to apply traction forces for fracture reduction, limb lengthening, or skeletal alignment, typically as part of a larger traction system. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JEC, regulated under 21 CFR 888.3040, within the Orthopedic medical specialty. This device is flagged as an implant because it involves penetration into osseous tissue.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SteriTrak
    Anjon Bremer Halo System
    DigiFix Sterile Kit
    PIP Fix
    Anjon Bremer Halo System
    Medline ReNewal Reprocessed Stryker External Fixation Devices
    DIGIFIX EXTERNAL FIXATION SYSTEM
    HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
    LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
    F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
    SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
    KLSA MARTIN HAND DISTRACTOR
    FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
    HOFFMANN II COMPACT BALTIMORE COUPLING
    WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
    ORTHOGUARD AB ANTIMICROBIAL SLEEVE
    SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
    AMC ANTIMICROBIAL PIN/WIRE SLEEVE
    AUTOGENESIS AUTOMATOR, MODEL M1000
    HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
    BREMER HALO SYSTEM TITANIUM SKULL PIN
    CENTRAFIX EXTERNAL FIXATOR
    AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
    AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
    HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
    STABLELOC II EXTERNAL FIXATOR
    MONOTUBE CARBON TUBE
    HOFFMANN II CARBON CONNECTING ROD
    MONOTUBE TUBE TO RING CLAMP
    TITANIUM TUBE TO TUBE CLAMP
    EZ FIX
    MONOTUBE TUBE-TO-TUBE CLAMP
    EXTERNAL FIXATOR
    HOFFMANN II EXTERNAL FIXATION SYSTEM
    ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
    EXTERNAL FIXATOR
    ACE PELVIC STABILIZER
    PELVIC C-CLAMP
    ACE UNILATERAL FIXATOR II
    TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
    HOWMEDICA MONOTUBE T-CONNECTOR
    HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
    SYSTEM III HALO RING
    HALO ESPRIT
    OSTEO EX-FI-RE
    BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
    ACE OPEN-BACK HALO RING
    CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
    OLIVE K-WIRES
    ACE WIRE TENSION CLAMP

    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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