Cleared Traditional

K223864 - Alignment System Cranial

K223864 is the FDA 510(k) clearance for Alignment System Cranial by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K223864 · Brainlab AG · Neurology device
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Sep 2023
Decision
260d
Days
Class 2
Risk

K223864 is an FDA 510(k) clearance for the Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on September 9, 2023 after a review of 260 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

Submission Details

510(k) Number K223864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2022
Decision Date September 09, 2023
Days to Decision 260 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 148d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K223864.
ClearPoint System (Software Version 2.2)
K233243 · ClearPoint Neuro, Inc. · Nov 2023
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · Medtronic Navigation, Inc. · Oct 2023
ClearPoint Array System (Version 1.2)
K232102 · ClearPoint Neuro, Inc. · Sep 2023
Zeta Cranial Navigation System
K230661 · Zeta Surgical · Sep 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
K223288 · Brainlab AG · Jul 2023
ROSA ONE Brain Application
K231103 · Medtech S.A.S · Jul 2023