Cleared Traditional

K253379 - Stealth AXiS Cranial clinical application

K253379 is an FDA 510(k) clearance for Stealth AXiS Cranial clinical application, manufactured by Medtronic Navigation, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K253379 · Medtronic Navigation, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
177d
Days
Class 2
Risk

K253379 is an FDA 510(k) clearance for the Stealth AXiS Cranial clinical application. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on March 26, 2026 after a review of 177 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Navigation, Inc. devices

FDA 510(k) Submission Details - K253379

510(k) Number K253379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date March 26, 2026
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 148d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 242
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K253379.
Zeta Navigation System
K253663 · Zeta Surgical, Inc. · May 2026
NeuroAlign software
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SOLOPASS 2.0 System
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Ball Joint Guide Array (66295)
K250893 · Bayer Medical Care, Inc. · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
K242575 · Brain Navi Biotechnology Co., Ltd. · May 2025