# K160363: Optimus CMF System

- Pathway: 510(k) (Special)
- Applicant: Osteonic Co., Ltd.
- Decided: Oct 20, 2016 after 254 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: 7 generations back to K761228 (1976). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140037: Optimus CMF System, Osteonic Co., Ltd. (2015) Summary page 4.

## Indications for use
Optimus CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including: 1. Fractures 2. Osteotomies 3. Reconstructive procedures 4. Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K160363
Methodology: https://510kreport.com/methodology