Cleared Traditional

K153248 - PEEK Customized Cranial Implant

K153248 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 Traditional 510(k) pathway after a 122-day FDA review.

K153248 · Stryker · Neurology device
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Mar 2016
Decision
122d
Days
Class 2
Risk

K153248 is an FDA 510(k) clearance for the PEEK Customized Cranial Implant. 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 March 10, 2016 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker devices

FDA 510(k) Submission Details - K153248

510(k) Number K153248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date March 10, 2016
Days to Decision 122 days
Submission Type Traditional
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
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 34
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K153248.
Sterile NS System
K170368 · Jeil Medical Corporation · Sep 2017
Stryker Universal Mesh
K161821 · Stryker · Dec 2016
Biopor Porous Polyethylene Implants
K161446 · Ceremed , Inc. · Sep 2016
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
K152076 · Stryker · Aug 2015
OPTIMUS NEURO SYSTEM
K141911 · Osteonic Co., Ltd. · Feb 2015
INNOVASIS CRANIAL SYSTEM
K141644 · Innovasis, Inc. · Nov 2014