# K033160: Synthes Sterile Low Profile Neuro Contourable Mesh Plates

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Oct 9, 2003 after 9 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Synches Low Profile Neuro System: named in the summary without a submission number

## Most influential descendants
- K123723: Synthes Matrixneuro Cranial Plating System (2013), 2 descendants of its own
- K140462: Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System) (2014), 1 descendant of its own
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own

## Indications for use
The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the mid face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K033160
Methodology: https://510kreport.com/methodology