# K253373: Southern Craniomaxillofacial (CMF) System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Medical (Pty), Ltd.
- Decided: Dec 19, 2025 after 80 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 5.

## Indications for use
The Southern MF System is a maxillofacial plate and screw system intended for osteotomy, reconstruction, and fracture fixation in midface, maxillofacial, and mandibular surgeries.

Source page: https://510kreport.com/device/K253373
Methodology: https://510kreport.com/methodology