Cleared Special

K152076 - PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152076 · Stryker · Neurology device
Download Printable Device Report (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.

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
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 41
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K152076.
TECHFIT Patient-Specific Cranial System
K250297 · Techfit Digital Surgery, Inc. · Oct 2025
Fusion Craniofacial Implant
K250334 · Kelyniam Global, Inc. · Jul 2025
VSP PEEK Cranial Implant
K231834 · 3D Systems, Inc. · Apr 2024
MCI-Neuro Fixation System
K212391 · Mci Medical Concept Innovation, Inc. · Oct 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
K210360 · Osteonic Co., Ltd. · Jan 2022
Stryker PEEK Customized Cranial Implant Kit
K203055 · Stryker · Feb 2021