Cleared Traditional

K141911 - OPTIMUS NEURO SYSTEM

K141911 is the FDA 510(k) clearance for OPTIMUS NEURO SYSTEM by Osteonic Co., Ltd.. It is a Class 2 Neurology device (product code GWO) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K141911 · Osteonic Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
210d
Days
Class 2
Risk

K141911 is an FDA 510(k) clearance for the OPTIMUS NEURO SYSTEM. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Osteonic Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on February 10, 2015 after a review of 210 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 Osteonic Co., Ltd. devices

Submission Details

510(k) Number K141911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2014
Decision Date February 10, 2015
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 148d · This submission: 210d
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 28
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K141911.
Stryker Universal Mesh
K161821 · Stryker · Dec 2016
PEEK Customized Cranial Implant
K153248 · Stryker · Mar 2016
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
K152076 · Stryker · Aug 2015
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452 · Jeil Medical Corporation · Jul 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · Synthes USA Products, LLC · Jun 2014
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker · Oct 2013