Cleared Traditional

K234047 - Automatic Registration

K234047 is the FDA 510(k) clearance for Automatic Registration by Brainlab AG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K234047 · Brainlab AG · Orthopedic device
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Mar 2024
Decision
90d
Days
Class 2
Risk

K234047 is an FDA 510(k) clearance for the Automatic Registration. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on March 20, 2024 after a review of 90 days - within the typical 510(k) review window.

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 K234047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2023
Decision Date March 20, 2024
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - 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.
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 - OLO Orthopedic Stereotaxic Instrument

All 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K234047.
DuraPro™ Oscillating System
K240568 · Globus Medical, Inc. · Apr 2024
Virage® Navigation System
K240647 · Zimvie Spine (Zimmer Biomet Spine, Inc.) · Apr 2024
Genesys Spine Sacroiliac Joint Fusion System with Navigation
K233595 · Genesys Spine · Mar 2024
Real Intelligence™ CORI™
K240139 · Blue Belt Technologies, Inc. · Mar 2024
Ortho Guidance Precision Knee Software
K233542 · Stryker Leibinger GmbH & Co KG · Mar 2024
OTS Hip
K232140 · Ortoma AB · Mar 2024