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OLO

Orthopedic Stereotaxic Instrument

Product code
OLO
Device name
Orthopedic Stereotaxic Instrument
Device class
Class 2
21 CFR
21 CFR 882.4560
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
440

FDA classification definition

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (133)

Last three years. Most recent: 2026-08-20.

NumberDecision dateApplicantDevice name
K2625062026-08-20Remex Medical Corp.Remex Spine Surgery Navigation - Universal Instrumen summary
K2614102026-07-30Suite 201, National Innovation CentreNavbit MARQ (PRD-001-SUP (Supine Registration Kit), summary
K2612052026-07-29Spineart SASPINEART Navigation Instrument System summary
K2610242026-07-24THINK Surgical, Inc.TMINI Miniature Robotic System summary
K2621212026-07-24SurGenTec, LLCIon-L Navigated Instruments summary
K2611132026-07-22Ecential RoboticsOp.n™ Spine Navigation and Robotic Guidance summary
K2618522026-07-01Ortoma ABOTS Hip summary
K2539212026-06-26Silony Medical GmbHVERTICALE® Navigation Instruments summary
K2604802026-06-25Depuy Ireland UCVELYS™ Robotic-Assisted Solution summary
K2603692026-06-20LEM Surgical AGDynamis Robotic Surgical System summary
K2616652026-06-18Providence Medical Technology, Inc.CORUS™ Navigation System-GN summary
K2605712026-06-02Life Spine, Inc.SIMPACT Sacroiliac Joint Fixation System GX Navigati summary
K2610602026-05-29Tyber Medical, LLCNavigated LLIF Impactable Tracker summary
K2541572026-05-26Medos International SARLCROSSNAV Navigation Enabled Instruments for Disc Pre summary
K2603292026-05-22SurGenTec, LLCIon-C Navigation Instruments summary
K2605822026-05-21Orthosoft Inc. (d/b/a) Zimmer CASROSA® Shoulder System summary
K2528802026-05-11Pytheas Navigation SasPytheas Your Guided Trajectory summary
K2600112026-04-16Foundation Surgical Group, Inc.Foundation Surgical Navigated Lateral Disc Prep Inst summary
K2541582026-04-09Spineart SASPINEART Navigation Instrument System summary
K2602402026-03-27Medos International SARLSYMPHONY Navigation Ready Instruments summary
K2606012026-03-26Blue Belt Technologies, Inc.REAL INTELLIGENCE™ CORI™ summary
K2520372026-03-25Curexo, Inc.CUVIS-joint (CJ150) summary
K2536042026-03-20SurGenTec, LLCTiLink-L Navigation Instruments summary
K2534442026-03-18MiRus, LLCEUROPA™ Posterior Cervical Fusion Navigated Instrume summary
K2605462026-03-17K2m, Inc.Q Pedicle Instruments summary
K2600102026-03-03THINK Surgical, Inc.TMINI® Miniature Robotic System summary
K2602222026-02-25Mako Surgical Corp.Mako Total Knee Application summary
K2529892026-02-20Point Robotics MedTech, Inc.“POINT” Kinguide Agile Hybrid Navigation System; DRF summary
K2536232026-02-19Stryker Leibinger GmbH & Co KGSpine Guidance 5.4 Software; Spine Guidance 5.4 Upgr summary
K2541482026-02-19Silony Medical GmbHVERTICALE GPS Instruments summary
K2525972026-02-19Alphatec Spine, Inc.Valence Robotic Navigation System; Valence Robotic N summary
K2533812026-02-12Medtronic Navigation, Inc.Stealth AXiS™ Surgical System with Stealth AXiS™ Spi summary
K2520582026-02-06Balmoral Medical, LLCROSA Knee System with UltraSound Imaging Platform (U summary
K2528712026-02-06Stryker Leibinger GmbH & Co KGSpine Guidance 5.3 Software; Q Interbody Instruments summary
K2528732026-02-06K2m, Inc.Q Interbody Instruments summary
K2520872026-02-03Ulrich Medical USA, Inc.Navigation Module of the Cortium® System summary
K2527552026-01-23Point Robotics MedTech, Inc.POINT Kinguide Agile Robotic Arm Surgical Stereotact summary
K2529622026-01-12Promethean Restorative, LLCDYNAMIS™ Navigation System summary
K2536612025-12-22THINK Surgical, Inc.TMINI Miniature Robotic System summary
K2529502025-12-15Proprio, Inc.Paradigm System summary
K2528412025-12-05Blue Belt Technologies, Inc.REAL INTELLIGENCE™ CORI™ XT (CORI XT) summary
K2519432025-12-04Spineology, Inc.Spineology Navigation Instruments summary
K2513142025-11-13Orthosoft Inc. (d/b/a) Zimmer CASRosa® Knee System summary
K2505992025-11-05Globus Medical, Inc.ExcelsiusGPS™ Instruments summary
K2520882025-10-31Orthofix US, LLCFirebird SI Navigation System summary
K2527422025-10-28Tyber Medical, LLCNavigated Instruments summary
K2505202025-10-27Osteocentric Technologies, Inc.OsteoCentric Navigated Instruments System summary
K2512822025-10-17Medtronic Navigation, Inc.StealthStation S8 Spine Software summary
K2525442025-10-10THINK Surgical, Inc.TMINI Miniature Robotic System summary
K2519712025-09-25Stryker InstrumentsRPS Primary TKA Software; RPS Console; RPS Saw One; summary
K2517802025-09-15SI-BONE, Inc.iGPS Navigation Instruments summary
K2525622025-09-12Brainlab AGSpine & Trauma Navigation Instruments summary
K2513162025-09-11Mazor Robotics , Ltd.Mazor X System / Mazor X Stealth Edition summary
K2501672025-08-18Evolution SpineEvolution Spine Navigation Instruments summary
K2510602025-07-30Providence Medical Technology, Inc.CORUS™ Navigation System-GX summary
K2510732025-07-23Innovasis, Inc.Innovasis Navigation Instruments (Vector G-E Navigat summary
K2508772025-06-20THINK Surgical, Inc.TMINI Miniature Robotic System summary
K2429332025-06-18Spineart SASPINEART Navigation Instrument System summary
K2424642025-06-05Medtronic Navigation, Inc.Stealth™ Spine Clamps; ModuLeX™ Shank Mounts summary
K2508792025-06-04Proprio, Inc.Paradigm System summary
K2513152025-05-29Remex Medical Corp.Anatase Spine Surgery Navigation System and Remex Sp summary
K2500862025-05-16Ortoma ABOTS Hip summary
K2434192025-05-08Altus Partners, LLCAltus Spine Navigation System summary
K2506082025-04-25Mako Surgical Corp.Mako Total Knee Application (3.0); Hybrid Tip Pointe summary
K2433262025-04-23LEM Surgical AGDynamis Robotic Surgical System summary
K2428062025-04-16Medyssey Co, Ltd.Medyssey Navigation System summary
K2435142025-04-03Spine Wave, Inc.Salvo® Robotic Navigation Instruments summary
K2436592025-04-02SeaSpine Orthopedics CorporationFLASH™ Facet Fusion Instruments, IsoTis® Facet Fusio summary
K2501822025-03-24Innovasis, Inc.Innovasis Navigation Instruments summary
K2439582025-03-21Stryker InstrumentsConsolidated Operating Room Equipment (CORE) 2 Conso summary
K2421212025-03-14Monogram Orthopaedics, Inc.mBôs (Monogram mBôs TKA System) summary
K2428902025-03-07Spineart SASPINEART Navigation Instrument System summary
K2429142025-03-07Ecential RoboticsOp.n(TM) Navigation summary
K2437512025-03-05Mako Surgical Corp.Mako Total Hip Application 5.0 summary
K2432582025-02-21Proprio, Inc.Paradigm System summary
K2433872025-01-29Gyder Surgical Pty, Ltd.GYDER® Hip System summary
K2438142025-01-10Globus Medical, Inc.NuVasive Pulse System summary
K2434812025-01-06THINK Surgical, Inc.TMINI Miniature Robotic System summary
K2436712024-12-20Globus Medical, Inc.ExcelsiusGPS® Instruments summary
K2435602024-12-13Remex Medical Corp.Remex Spine Surgery Navigation Instrument summary
K2430732024-12-06GS Medical Co., Ltd.AnyPlus Navigated Instruments System summary
K2432852024-11-15THINK Surgical, Inc.TMINI Miniature Robotic System summary
K2423732024-11-07Mako Surgical Corp.Mako Shoulder Application (1.0) summary
K2428642024-10-18Orthosoft Inc. (d/b/a) Zimmer CASROSA® Knee System summary
K2401602024-10-17Astura MedicalEGPS Navigated Instruments summary
K2418932024-09-16Medos International SARLCROSSNAV Navigation Enabled Instruments and UNAS Nav summary
K2415172024-08-27Stryker Leibinger GmbH & Co KGQ Guidance System; Mako Spine System; summary
K2422642024-08-23THINK Surgical, Inc.TMINI Miniature Robotic System summary
K2420092024-08-08Kico Knee Innovation Company Pty, Ltd.360CAS Knee summary
K2416442024-08-07Spineart SASPINEART Navigation Instrument System summary
K2337062024-08-02NuvasiveBendini Cloud Application summary
K2337252024-07-26Medivis, Inc.Spine Navigation System summary
K2411712024-07-25Stryker Leibinger GmbH & Co KGSpine Guidance Software (Version 5.1); Consolidated summary
K2411302024-07-24Point Robotics MedTech, Inc.“POINT” Kinguide Agile Hybrid Navigation System (PSH summary
K2410312024-07-12THINK Surgical, Inc.TMINI Miniature Robotic System (TMINI 1.1) summary
K2416252024-07-05Remex Medical Corp.Anatase Navi Disposable Instrument summary
K2332552024-06-17DePuy SynthesCROSSNAV Navigation Enabled Instruments summary
K2332562024-06-17DePuy SynthesRobotic Integration Instruments summary
K2407212024-06-14Globus Medical, Inc.ExcelsiusFlex™ summary
K2410822024-06-14Innosys Co., Ltd.INNOVERSE Navigation Instruments summary
K2332542024-06-14DePuy SynthesTELIGEN System Navigation Ready Instruments summary
K2332282024-06-14Ecential RoboticsSpine Navigation and Robotic-Assistance Device summary
K2410112024-06-11Mako Surgical Corp.Mako Total Knee Application summary
K2406622024-06-06Stryker Leibinger GmbH & Co KGSpine Guidance Software (version 5.0); Xia 3/ Serrat summary
K2409512024-06-06Alphatec SpineInvictus Robotic Navigation Instruments summary
K2402112024-06-05Depuy Ireland UCVELYS Robotic-Assisted Solution summary
K2407012024-05-23Brainlab AGDrill Guide; Drill Bit; Spine & Trauma Navigation summary
K2406252024-05-03Providence Medical Technology, Inc.CORUS Navigation Access System summary
K2335132024-05-01Remex Medical Corp.Remex Spine Surgery Navigation System II summary
K2400622024-04-29Insight Medical Systems, Inc.ARVIS® Shoulder summary
K2405682024-04-29Globus Medical, Inc.DuraPro™ Oscillating System summary
K2406472024-04-05Zimvie Spine (Zimmer Biomet Spine, IncVirage® Navigation System summary
K2335952024-03-29Genesys SpineGenesys Spine Sacroiliac Joint Fusion System with Na summary
K2340472024-03-20Brainlab AGAutomatic Registration summary
K2401392024-03-18Blue Belt Technologies, Inc.Real Intelligence™ CORI™ summary
K2335422024-03-14Stryker Leibinger GmbH & Co KGOrtho Guidance Precision Knee Software; Ortho Guidan summary
K2321402024-03-11Ortoma ABOTS Hip summary
K2301952024-03-08Comerge AGNeo ADVISE software summary
K2328002024-02-23SI-BONE, Inc.Navigation Tracking Instruments summary
K2331992024-02-21Orthosoft Inc (D/B/A Zimmer Cas)ROSA® Shoulder System summary

13 more not listed.

Official FDA classification page: OLO
Classification and pathway per current FDA publications. Data from openFDA (CC0).