Cleared Traditional

K253381 - Stealth AXiS Surgical System with Steal...

K253381 is the FDA 510(k) clearance for Stealth AXiS Surgical System with Steal... by Medtronic Navigation, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K253381 · Medtronic Navigation, Inc. · Orthopedic device
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Feb 2026
Decision
135d
Days
Class 2
Risk

K253381 is an FDA 510(k) clearance for the Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on February 12, 2026 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Navigation, Inc. devices

Submission Details

510(k) Number K253381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date February 12, 2026
Days to Decision 135 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K253381.
Valence Robotic Navigation System
K252597 · Alphatec Spine, Inc. · Feb 2026
Spine Guidance 5.4 Software
K253623 · Stryker Leibinger GmbH & Co KG · Feb 2026
VERTICALE GPS Instruments
K254148 · Silony Medical GmbH · Feb 2026
ROSA Knee System with UltraSound Imaging Platform (USIP)
K252058 · Balmoral Medical, LLC · Feb 2026
Spine Guidance 5.3 Software
K252871 · Stryker Leibinger GmbH & Co KG · Feb 2026
Q Interbody Instruments
K252873 · K2m, Inc. · Feb 2026