Cleared Special

K152076 - PEEK Customized Cranial Implant

K152076 is the FDA 510(k) clearance for PEEK Customized Cranial Implant by Stryker. It is a Class 2 Neurology device (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)
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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.

View all Stryker devices

Submission Details

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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 21
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K152076.
Stryker Universal Mesh
K170725 · Stryker · Nov 2017
Stryker Universal Mesh
K161821 · Stryker · Dec 2016
PEEK Customized Cranial Implant
K153248 · Stryker · Mar 2016
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker · Oct 2013
RESORB-X G
K121606 · KLS-Martin L.P. · Jan 2013
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
K121153 · Stryker · Sep 2012