# K082335: Synthes Matrixmandible Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 10, 2008 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes MatrixMANDIBLE Plate and Screw System: named in the summary without a submission number
- (no number) Synthes SMF Self-Drilling Screws: named in the summary without a submission number

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

## Indications for use
The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

Source page: https://510kreport.com/device/K082335
Methodology: https://510kreport.com/methodology