Cleared Traditional

K212194 - Stryker Q Guidance System with Cranial ...

K212194 is the FDA 510(k) clearance for Stryker Q Guidance System with Cranial ... by Stryker Corporation. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 582-day FDA review.

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.

View all Stryker Corporation devices

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.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 217
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