# K212391: MCI-Neuro Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Mci Medical Concept Innovation, Inc.
- Decided: Oct 21, 2022 after 445 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: 6 generations back to K953806 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

Source page: https://510kreport.com/device/K212391
Methodology: https://510kreport.com/methodology