Cleared Special

K152076 - PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority

K152076 is an FDA 510(k) clearance for PEEK Customized Cranial Implant, manufactured by Stryker. The device is a Class 2 Neurology device with product code GWO cleared through the Special 510(k) pathway after a 30-day FDA review.

K152076 · Stryker · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
30d
Days
Class 2
Risk

K152076 is an FDA 510(k) clearance for the PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on August 26, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - 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 - K152076

510(k) Number K152076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2015
Decision Date August 26, 2015
Days to Decision 30 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: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GWO Device Classification - Class 2, Special Controls

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
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 - GWO Plate, Cranioplasty, Preformed, Alterable

All 41
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K152076.
Stryker Universal Mesh
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K161446 · Ceremed , Inc. · Sep 2016
PEEK Customized Cranial Implant
K153248 · Stryker · Mar 2016
ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
K141123 · Alliance Partners, LLC · Feb 2015
OPTIMUS NEURO SYSTEM
K141911 · Osteonic Co., Ltd. · Feb 2015
INNOVASIS CRANIAL SYSTEM
K141644 · Innovasis, Inc. · Nov 2014
K152076 · PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
Download PDF FDA Summary Stryker