Cleared Special

K171152 - Stryker Universal Neuro III System AXS ...

K171152 is an FDA 510(k) clearance for Stryker Universal Neuro III System AXS ..., manufactured by Stryker. The device is a Class 2 Neurology device with product code HBW cleared through the Special 510(k) pathway after a 29-day FDA review.

K171152 · Stryker · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
29d
Days
Class 2
Risk

K171152 is an FDA 510(k) clearance for the Stryker Universal Neuro III System AXS Screw. Classified as Fastener, Plate, Cranioplasty (product code HBW), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on May 19, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5360 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker devices

FDA 510(k) Submission Details - K171152

510(k) Number K171152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2017
Decision Date May 19, 2017
Days to Decision 29 days
Submission Type Special
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
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

HBW Device Classification - Class 2, Special Controls

Product Code HBW Fastener, Plate, Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5360
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 - HBW Fastener, Plate, Cranioplasty

Devices cleared under the same product code (HBW) and FDA review panel - the closest regulatory comparables to K171152.
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