# K083388: Synthes Matrixorthognathis Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 12, 2009 after 115 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 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 Craniofacial Plates: named in the summary without a submission number
- (no number) Synthes Craniofacial Plate and Screw System: named in the summary without a submission number
- (no number) Synthes 1.5mm/2.0mm Orthognathic Maxillary Plates: named in the summary without a submission number
- (no number) Synthes SMF Titanium Alloy Bone Screws: named in the summary without a submission number
- (no number) XsorbTM Bioabsorbable Craniofacial Fixation 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
- K170272: TruMatch CMF Titanium 3D Printed Implant System (2017), 5 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own

## Recalls of this device
- Jun 24, 2015 · Class II · Z-2272-2015: The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.

## Indications for use
The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use: Fractures of the midface and craniofacial skeleton LeFort I osteotomies, sagittal split osteotomies and genioplasties Orthognathic surgery including reconstructive procedures

Source page: https://510kreport.com/device/K083388
Methodology: https://510kreport.com/methodology