# K063790: The Synthes Matrixmandible Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 16, 2007 after 115 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.
22 later devices descend from it; 7 cite it directly.
0 of 23 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 2.4 mm Universal Locking Plate System: named in the summary without a submission number
- (no number) Synthes 2.0 Locking Plate System: named in the summary without a submission number
- (no number) Synthes Mandibular Modular Fixation System: named in the summary without a submission number
- (no number) Stryker Leibinger NewGen System: named in the summary without a submission number

## Most influential descendants
- K170272: TruMatch CMF Titanium 3D Printed Implant System (2017), 5 descendants of its own
- K122647: Synthes Patient Specific Plate (2013), 5 descendants of its own
- K113567: Synthes Matrixmadible Plate and Screw System (2012), 4 descendants of its own
- K132519: Stryker Customized Mandible Recon Plate Kit (2013), 3 descendants of its own
- K173039: TruMatch CMF Titanium 3D Printed Implant (2018), 2 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/K063790
Methodology: https://510kreport.com/methodology