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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
    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
    NOVA Minimally Invasive System
    GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
    MSFX MIKRON SPINAL FIXATION SYSTEM
    TriALTIS™ Spine System
    Pitkar Spinal Pedicle Screw System
    Eminent Spine Scoliosis Deformity Pedicle Screw System
    Orthopeasia Spinal Fixation System
    Cortera™ Spinal Fixation System
    CarboClear® X Pedicle Screw System
    Pantheon Pedicle Screw and Iliac Bolt Fixation System
    Erisma® Lp Spinal Fixation System; Erisma® LP MIS
    Invictus® Small Stature Spinal Fixation System
    Spinal System
    Ingenix Spinal System
    Vector™ Pedicle Screw System
    JAZZ Spinal System
    Salvo® Spine System
    POWEReam Xia/Serrato
    Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
    CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
    NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
    G Surgical Marksman MIS System
    AnyPlus II Spinal Fixation System
    CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
    Vital™ Spinal Fixation System
    4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
    VADER® Pedicle 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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