Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → OLO — Orthopedic Stereotaxic Instrument # OLO · Orthopedic Stereotaxic Instrument _Neurology · 21 CFR 882.4560 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO ## Overview - **Product Code:** OLO - **Device Name:** Orthopedic Stereotaxic Instrument - **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 423) Showing 20 most recent of 423 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260011](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260011.md) | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Apr 16, 2026 | SESE | | [K254158](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K254158.md) | SPINEART Navigation Instrument System | Spineart SA | Apr 9, 2026 | SESE | | [K260240](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260240.md) | SYMPHONY Navigation Ready Instruments | Medos International SARL | Mar 27, 2026 | SESE | | [K260601](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260601.md) | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | Mar 26, 2026 | SESE | | [K252037](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252037.md) | CUVIS-joint (CJ150) | Curexo, Inc. | Mar 25, 2026 | SESE | | [K253604](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K253604.md) | TiLink-L Navigation Instruments | SurGenTec, LLC | Mar 20, 2026 | SESE | | [K253444](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K253444.md) | EUROPA™ Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | Mar 18, 2026 | SESE | | [K260546](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260546.md) | Q Pedicle Instruments | K2m, Inc. | Mar 17, 2026 | SESE | | [K260010](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260010.md) | TMINI® Miniature Robotic System | THINK Surgical, Inc. | Mar 3, 2026 | SESE | | [K260222](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260222.md) | Mako Total Knee Application | Mako Surgical Corp. | Feb 25, 2026 | SESE | | [K252989](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252989.md) | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | Feb 20, 2026 | SESE | | [K254148](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K254148.md) | VERTICALE GPS Instruments | Silony Medical GmbH | Feb 19, 2026 | SESE | | [K253623](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K253623.md) | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co KG | Feb 19, 2026 | SESE | | [K252597](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252597.md) | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | Feb 19, 2026 | SESE | | [K253381](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K253381.md) | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | Medtronic Navigation, Inc. | Feb 12, 2026 | SESE | | [K252873](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252873.md) | Q Interbody Instruments | K2m, Inc. | Feb 6, 2026 | SESE | | [K252871](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252871.md) | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | Feb 6, 2026 | SESE | | [K252058](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252058.md) | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | Feb 6, 2026 | SESE | | [K252087](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252087.md) | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | Feb 3, 2026 | SESE | | [K252755](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO/K252755.md) | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | Jan 23, 2026 | SESE | ## Top Applicants - Brainlab AG — 21 clearances - Mako Surgical Corp. — 19 clearances - Blue Belt Technologies, Inc. — 18 clearances - THINK Surgical, Inc. — 18 clearances - Medtronic Sofamor Danek USA, Inc. — 15 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com