Cleared Traditional

K153248 - PEEK Customized Cranial Implant

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

K153248 · Stryker · Neurology device
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Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K153248.
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