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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: NKB FDA class 2

    Thoracolumbosacral Pedicle Screw System

    Orthopedic

    View full classification →

    The Thoracolumbosacral Pedicle Screw System is an orthopedic implant intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to spinal fusion surgery. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKB and regulation 21 CFR 888.3070 in the Orthopedic specialty. The device is flagged as an implant but is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    “Socko” Vimax Spinal Fixation System
    ChanPin Pedicle Screw Spinal System
    Varion Thoracolumbar Fixation System
    SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
    AccelFix Spinal Fixation System
    PERLA® TL Posterior Thoraco-lumbar Fixation System
    LEO Spinal System
    M.U.S.T. Pedicle Screw System - Extension
    CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System
    ARx® SAI Implant System
    KHEIRON® Spinal Fixation System, including patient specific K-ROD
    OSTEOMNI SPINAL FIXATION SYSTEM
    Duet™ Spinal Fixation System
    Vulcan Spinal System
    Swedge™ Pedicle Screw Fixation System Bezier Rod
    CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
    KHEIRON® Spinal Fixation System, including patient specific K-ROD
    KHEIRON® Spinal Fixation System, including patient specific K-ROD
    Vital™ Spinal Fixation System
    Universal Spinal System
    Fule Spinal Fixation System
    CD Horizon™ Spinal System
    OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
    TriALTIS™ Spine System
    A8 INTEGR8™ Porous Pedicle Screws
    PressON Spinal Fixation System
    JAZZ Spinal System
    KHEIRON® Spinal Fixation System, including patient specific K-ROD
    Momentum® Posterior Spinal Fixation System
    Virata Spinal Fixation System
    RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
    Annex® 2 Adjacent Level System
    COLONNADE Posterior Screw Fixation System
    Eminent Spine 3D Titanium Pedicle Screw System
    HC Biologics Osteopoint Spinal Fixation System
    VADER® Pedicle System and VADER®one Pedicle System
    Primus Spinal Fixation System
    Tiger 2 System
    TriALTIS™ Spine System
    EffortMed Spinal Fixation System
    MASADA Modular Spinal Fixation System
    NEO Pedicle Screw System™
    Reform Pedicle Screw System
    LOCK-IN Spinal Fixation System
    4CIS® Chiron Spinal Fixation System
    MediRod Pedicle Screw System
    Xpine Spinal Fixation System
    CarboClear® Hybrid Pedicle Screw System
    Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
    CD Horizon™ Spinal 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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