# K100205: Frontier Devices Neuro System

- Pathway: 510(k) (Traditional)
- Applicant: Folsom Metal Products, Inc.
- Decided: Dec 13, 2010 after 322 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: 2 generations back to K953806 (1996). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042987: Modification to Synthes Cranial Plates, Synthes (Usa) (2004) Summary page 1.
- K072758: Synthes (Usa) 2.0MM Titanium T-Plate, Synthes (Usa) (2007) Summary page 1.
- K974206: Synthes Cranial Spring Clip (CSC), Synthes (Usa) (1998) Summary page 1.

## Most influential descendants
- K141911: Optimus Neuro System (2015), 4 descendants of its own
- K183352: Optimus Neuro System (2019), 2 descendants of its own
- K190811: Optimus NEURO System - Sterile Kit (2019), 1 descendant of its own
- K212391: MCI-Neuro Fixation System (2022), 0 descendants of its own
- 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 Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.

Source page: https://510kreport.com/device/K100205
Methodology: https://510kreport.com/methodology