Cleared Traditional

K242569 - Mixed Reality Spine Navigation

K242569 is the FDA 510(k) clearance for Mixed Reality Spine Navigation by Brainlab AG. It is a Class 2 Orthopedic device (product code SBF) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K242569 · Brainlab AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
261d
Days
Class 2
Risk

K242569 is an FDA 510(k) clearance for the Mixed Reality Spine Navigation. Classified as Orthopedic Augmented Reality (product code SBF), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on May 16, 2025 after a review of 261 days - an extended review cycle.

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 Brainlab AG devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 122d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SBF Orthopedic Augmented Reality
Device Class Class 2 - 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.
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 - SBF Orthopedic Augmented Reality

All 41
Devices cleared under the same product code (SBF) and FDA review panel - the closest regulatory comparables to K242569.
NextAR(TM) Spine
K250477 · Medacta International S.A. · Jul 2025
OptiVu™ Shoulder
K250108 · Mr Surgical Solutions, LLC · Jul 2025
ExcelsiusXR™
K241525 · Globus Medical, Inc. · Jul 2025
ARVIS Surgical Navigation System
K243980 · Kico Knee Innovation Company Pty Limited · Mar 2025
Knee+
K243975 · Pixee Medical · Mar 2025
xvision Spine system
K250255 · Augmedics, Ltd. · Mar 2025