# K121574: Synthes Matrixmadible Plate and Screw System

- Pathway: 510(k) (Special)
- Applicant: Synthes, Inc.
- Decided: Jun 29, 2012 after 30 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: 1 generation back to K954385 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- K954385: Synthes Mandibular Modular Fixation System, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
The Synthes MatrixMLANDIBLE plate and screw system is intended for oral, maxillofacial surgery: * Trauma *Reconstructive surgery * Orthognathic surgery (surgical correction of dentofacial deformities)

Source page: https://510kreport.com/device/K121574
Methodology: https://510kreport.com/methodology