Cleared Traditional

K190229 - Stryker PEEK Customized Cranial Implant...

K190229 is the FDA 510(k) clearance for Stryker 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 156-day FDA review.

K190229 · Stryker · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
156d
Days
Class 2
Risk

K190229 is an FDA 510(k) clearance for the Stryker PEEK Customized Cranial Implant Kit. 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 July 11, 2019 after a review of 156 days - an extended review cycle.

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 K190229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2019
Decision Date July 11, 2019
Days to Decision 156 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
8d slower than avg
Panel avg: 148d · This submission: 156d
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 27
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K190229.
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
Optimus NEURO System - Sterile Kit
K190811 · Osteonic Co., Ltd. · Nov 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
K182711 · Kelyniam Global, Inc. · May 2019
Optimus Neuro System
K183352 · Osteonic Co., Ltd. · Jan 2019
Universal Mesh - Sterile
K182425 · Stryker Leibinger GmbH & Co KG · Nov 2018