Cleared Special

K151387 - Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade

K151387 is an FDA 510(k) clearance for Stryker Universal Neuro III System: UN ..., 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.

K151387 · Stryker · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
29d
Days
Class 2
Risk

K151387 is an FDA 510(k) clearance for the Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver .... Classified as Fastener, Plate, Cranioplasty (product code HBW), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on June 24, 2015 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.

FDA 510(k) Submission Details - K151387

510(k) Number K151387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date June 24, 2015
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
120d faster than avg
Panel avg: 149d · 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 K151387.
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
K251472 · Inion OY · Jul 2025
Stryker Resorbable Fixation System
K231208 · Stryker Leibinger GmbH & Co KG · Aug 2023
Stryker Universal Neuro III System AXS Screw
K171152 · Stryker · May 2017
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K141385 · Depuy Synthes Companies of Johnson & Johnson · Mar 2015
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
K101835 · Porex Surgical, Inc. · Dec 2010
MEMOGRAPH
K001353 · Biomedical Ent., Inc. · Mar 2001
K151387 · Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
Download PDF FDA Summary Stryker