# K190811: Optimus NEURO System - Sterile Kit

- Pathway: 510(k) (Traditional)
- Applicant: Osteonic Co., Ltd.
- Decided: Nov 27, 2019 after 243 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K953806 (1996). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183352: Optimus Neuro System, Osteonic Co., Ltd. (2019) Summary page 4.
- K141911: Optimus Neuro System, Osteonic Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K210360: 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) (2022), 0 descendants of its own

## Indications for use
The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

Source page: https://510kreport.com/device/K190811
Methodology: https://510kreport.com/methodology