Cleared Traditional

K242569 - Mixed Reality Spine Navigation (FDA 510(k) Clearance)

K242569 · Brainlab AG · Orthopedic device
May 2025
Decision
261d
Days
Class 2
Risk

K242569 is an FDA 510(k) clearance for the Mixed Reality Spine Navigation. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4560. 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..

Submission Details

510(k) Number K242569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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.