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/productcode/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 429)

Showing 20 most recent of 429 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260571](/device/K260571.md) | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | Jun 2, 2026 | SESE |
| [K261060](/device/K261060.md) | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | May 29, 2026 | SESE |
| [K254157](/device/K254157.md) | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | May 26, 2026 | SESE |
| [K260329](/device/K260329.md) | Ion-C Navigation Instruments | SurGenTec, LLC | May 22, 2026 | SESE |
| [K260582](/device/K260582.md) | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | May 21, 2026 | SESE |
| [K252880](/device/K252880.md) | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | May 11, 2026 | SESE |
| [K260011](/device/K260011.md) | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Apr 16, 2026 | SESE |
| [K254158](/device/K254158.md) | SPINEART Navigation Instrument System | Spineart SA | Apr 9, 2026 | SESE |
| [K260240](/device/K260240.md) | SYMPHONY Navigation Ready Instruments | Medos International SARL | Mar 27, 2026 | SESE |
| [K260601](/device/K260601.md) | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | Mar 26, 2026 | SESE |
| [K252037](/device/K252037.md) | CUVIS-joint (CJ150) | Curexo, Inc. | Mar 25, 2026 | SESE |
| [K253604](/device/K253604.md) | TiLink-L Navigation Instruments | SurGenTec, LLC | Mar 20, 2026 | SESE |
| [K253444](/device/K253444.md) | EUROPA™ Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | Mar 18, 2026 | SESE |
| [K260546](/device/K260546.md) | Q Pedicle Instruments | K2m, Inc. | Mar 17, 2026 | SESE |
| [K260010](/device/K260010.md) | TMINI® Miniature Robotic System | THINK Surgical, Inc. | Mar 3, 2026 | SESE |
| [K260222](/device/K260222.md) | Mako Total Knee Application | Mako Surgical Corp. | Feb 25, 2026 | SESE |
| [K252989](/device/K252989.md) | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | Feb 20, 2026 | SESE |
| [K254148](/device/K254148.md) | VERTICALE GPS Instruments | Silony Medical GmbH | Feb 19, 2026 | SESE |
| [K253623](/device/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](/device/K252597.md) | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | Feb 19, 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/productcode/OLO](https://fda.innolitics.com/productcode/OLO)

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