# K182758: MCI - CMF System

- Pathway: 510(k) (Traditional)
- Applicant: Mci Medical Concept Innovation, Inc.
- Decided: Dec 5, 2019 after 433 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980512 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180204: CranioMaxillofacial Fixation (CMF) System - CMF Visionare, Visionare, LLC (2018). Cleared while this submission was under review Summary page 4.

## Indications for use
MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Source page: https://510kreport.com/device/K182758
Methodology: https://510kreport.com/methodology