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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: OLO FDA class 2

    Orthopedic Stereotaxic Instrument

    Neurology

    View full classification →

    The Orthopedic Stereotaxic Instrument (product code OLO) is a Class 2 device regulated under 21 CFR 882.4560 in the Neurology specialty (NE), cleared through the 510(k) pathway and reviewed by the Orthopedic panel. It provides stereotaxic guidance during orthopedic surgical procedures including joint or spine surgery, and is distinct from neurological stereotaxic instruments classified under product code HAW. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TMINI Miniature Robotic System
    SPINEART Navigation Instrument System
    Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
    Paradigm System
    Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
    OTS Hip
    Altus Spine Navigation System
    Mako Total Knee Application (3.0); Hybrid Tip Pointer
    Dynamis Robotic Surgical System
    Medyssey Navigation System
    Salvo® Robotic Navigation Instruments
    FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
    Innovasis Navigation Instruments
    Consolidated Operating Room Equipment (CORE) 2 Console
    mBôs (Monogram mBôs TKA System)
    SPINEART Navigation Instrument System
    Op.n(TM) Navigation
    Mako Total Hip Application 5.0
    Paradigm System
    GYDER® Hip System
    NuVasive Pulse System
    TMINI Miniature Robotic System
    ExcelsiusGPS® Instruments
    Remex Spine Surgery Navigation Instrument
    AnyPlus Navigated Instruments System
    TMINI Miniature Robotic System
    Mako Shoulder Application (1.0)
    ROSA® Knee System
    EGPS Navigated Instruments
    CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
    Q Guidance System; Mako Spine System;
    TMINI Miniature Robotic System
    360CAS Knee
    SPINEART Navigation Instrument System
    Bendini Cloud Application
    Spine Navigation System
    Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories
    “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
    TMINI Miniature Robotic System (TMINI 1.1)
    Anatase Navi Disposable Instrument
    CROSSNAV Navigation Enabled Instruments
    Robotic Integration Instruments
    INNOVERSE Navigation Instruments
    TELIGEN System Navigation Ready Instruments
    ExcelsiusFlex™
    Spine Navigation and Robotic-Assistance Device
    Mako Total Knee Application
    Invictus Robotic Navigation Instruments
    Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
    VELYS Robotic-Assisted Solution

    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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