Cleared Traditional

K190811 - Optimus NEURO System - Sterile Kit

K190811 is an FDA 510(k) clearance for Optimus NEURO System - Sterile Kit, manufactured by Osteonic Co., Ltd.. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K190811 · Osteonic Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
243d
Days
Class 2
Risk

K190811 is an FDA 510(k) clearance for the Optimus NEURO System - Sterile Kit. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 27, 2019 after a review of 243 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

FDA 510(k) Submission Details - K190811

510(k) Number K190811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2019
Decision Date November 27, 2019
Days to Decision 243 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
95d slower than avg
Panel avg: 148d · This submission: 243d
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 38
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K190811.
MCI-Neuro Fixation System
K212391 · Mci Medical Concept Innovation, Inc. · Oct 2022
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
Stryker PEEK Customized Cranial Implant Kit
K190229 · Stryker · Jul 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
K182711 · Kelyniam Global, Inc. · May 2019
Optimus Neuro System
K183352 · Osteonic Co., Ltd. · Jan 2019