Cleared Special

K140462 - MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)

K140462 is an FDA 510(k) clearance for MATRIXNEURO PREFORMED MESH (PART OF THE..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Neurology device with product code GWO cleared through the Special 510(k) pathway after a 109-day FDA review.

K140462 · Synthes USA Products, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
109d
Days
Class 2
Risk

K140462 is an FDA 510(k) clearance for the MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM). Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on June 13, 2014 after a review of 109 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140462

510(k) Number K140462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date June 13, 2014
Days to Decision 109 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
40d faster than avg
Panel avg: 149d · This submission: 109d
Pathway characteristics
Modification to existing cleared device.

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 43
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K140462.
OPTIMUS NEURO SYSTEM
K141911 · Osteonic Co., Ltd. · Feb 2015
INNOVASIS CRANIAL SYSTEM
K141644 · Innovasis, Inc. · Nov 2014
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452 · Jeil Medical Corporation · Jul 2014
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker · Oct 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K123723 · Synthes · Sep 2013
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
K122049 · Kinamed, Inc. · Apr 2013
K140462 · MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
Download PDF FDA Summary Synthes USA Products,…