# K140037: Optimus CMF System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonic Co., Ltd.
- Decided: Jan 20, 2015 after 378 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: 6 generations back to K761228 (1976). 37 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112457: Leforte System Bone Plate & Screw, Arkin Consulting Group (2012) Summary page 4.
- K113567: Synthes Matrixmadible Plate and Screw System, Synthes, Inc. (2012) Summary page 4.
- K121589: Biomet Microfixation Facial Plating System, Biomet Microfixation (2012) Summary page 4.
- K953806: Synthes (Usa) Midfacial System, Synthes (Usa) (1996) Summary page 4.
- K983485: Synthes 1.3 MM Self-Drilling Screw, Synthes (Usa) (1998) Summary page 4.
- K963030: Leibinger Imf Screw, Howmedica Leibinger, Inc. (1997) Summary page 4.
- K040272: Synthes (Usa) Craniofacial Plates, Synthes (Usa) (2004) Summary page 4.
- K091679: Leforte System Bone Plate, Jeil Medical Corporation (2009) Summary page 4.

## Most influential descendants
- K253373: Southern Craniomaxillofacial (CMF) System (2025), 0 descendants of its own
- K160363: Optimus CMF System (2016), 0 descendants of its own

## 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/K140037
Methodology: https://510kreport.com/methodology