# K080331: Synthes Craniofacial Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 30, 2008 after 84 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.
25 later devices descend from it; 5 cite it directly.
0 of 26 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 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
- 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
- K123786: Stryker Universal Orbital Floor System (2013), 3 descendants of its own

## Indications for use
The Synthes Craniofacial Plate and Screw 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 and chin.

Source page: https://510kreport.com/device/K080331
Methodology: https://510kreport.com/methodology