# K113251: Synthes Matrixmandible Performed Reconstruction Plates

- Pathway: 510(k) (Special)
- Applicant: Synthes, Inc.
- Decided: Dec 21, 2011 after 48 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 K091144 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091144: Synthes Matrixmandible Preformed Reconstruction Plates, Synthes (Usa) (2009) Summary page 1.

## Indications for use
The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

Source page: https://510kreport.com/device/K113251
Methodology: https://510kreport.com/methodology