# K113567: Synthes Matrixmadible Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes, Inc.
- Decided: Nov 19, 2012 after 353 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: 2 generations back to K954385 (1996). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063790: The Synthes Matrixmandible Plate and Screw System, Synthes (Usa) (2007) Summary page 1.
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS), Synthes (Usa) (1998) Summary page 1.

## Most influential descendants
- K140037: Optimus CMF System (2015), 2 descendants of its own
- K253373: Southern Craniomaxillofacial (CMF) System (2025), 0 descendants of its own
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own
- K160363: Optimus CMF System (2016), 0 descendants of its own

## Indications for use
The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery: * Trauma * Reconstructive surgery * Orthogntthic surgery (surgical correction of dento facial deformities)

Source page: https://510kreport.com/device/K113567
Methodology: https://510kreport.com/methodology