Cleared Traditional

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker (K162929) - FDA 510(k) Clearance

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

K162929 · Stryker Corporation · Neurology device
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Feb 2017
Decision
126d
Days
Class 2
Risk

K162929 is an FDA 510(k) clearance for the Stryker Navigation System with CranialMap software application, Stryker Crani.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Corporation (Freiburg Baden-Wurttemberg, DE). The FDA issued a Cleared decision on February 22, 2017 after a review of 126 days - within the typical 510(k) review window.

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 Stryker Corporation devices

Submission Details

510(k) Number K162929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2016
Decision Date February 22, 2017
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
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 163
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K162929.
neuromate Gen III
K180206 · Renishaw Mayfield Sarl · Apr 2018
ROSA BRAIN (v3.0.0.5)
K172444 · Medtech S.A · Mar 2018
Microscope Navigation Software
K172820 · Brainlab AG · Mar 2018
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K122096 · KARL STORZ Endoscopy-America, Inc. · Sep 2012
IPLAN
K101627 · Brainlab AG · Jun 2011
DISPOSABLE REFLECTIVE MARKER SPHERES
K100038 · Brainlab AG · Jul 2010