# K091144: Synthes Matrixmandible Preformed Reconstruction Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 25, 2009 after 127 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.
21 later devices descend from it; 4 cite it directly.
0 of 22 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

## Most influential descendants
- K102641: Mini and  Micro Fragments Reconstruction System-Neoface (2010), 12 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K122647: Synthes Patient Specific Plate (2013), 5 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K132519: Stryker Customized Mandible Recon Plate Kit (2013), 3 descendants of its own

## 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/K091144
Methodology: https://510kreport.com/methodology