Cleared Traditional

Stealth AXiS? Surgical System with Stealth AXiS? Spine clinical application

K253381 · Medtronic Navigation, Inc. · Orthopedic

Feb 2026

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K253381 is an FDA 510(k) clearance for the Stealth AXiS? Surgical System with Stealth AXiS? Spine clinical application, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on February 12, 2026, 135 days after receiving the submission on September 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K253381 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — 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.