Cleared Traditional

K212194 - Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212194 · Stryker Corporation · Neurology device

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Feb 2023

Decision

582d

Days

Class 2

Risk

K212194 is an FDA 510(k) clearance for the Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Corporation (Freiburg, DE). The FDA issued a Cleared decision on February 16, 2023 after a review of 582 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

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Submission Details

510(k) Number	K212194 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 14, 2021
Decision Date	February 16, 2023
Days to Decision	582 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

434d slower than avg

Panel avg: 148d · This submission: 582d

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.