Cleared Traditional

Mixed Reality Spine Navigation

K242569 · Brainlab AG · Orthopedic

May 2025

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K242569 is an FDA 510(k) clearance for the Mixed Reality Spine Navigation, a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on May 16, 2025, 261 days after receiving the submission on August 28, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K242569 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2024
Decision Date	May 16, 2025
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	SBF — Orthopedic Augmented Reality
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As ?augmented Reality? Stereoscopic Images To Intraoperatively Augment The User?s Field Of View.