# K140462: Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)

- Pathway: 510(k) (Special)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jun 13, 2014 after 109 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022012 (2002). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123723: Synthes Matrixneuro Cranial Plating System, Synthes (2013) Summary page 1.

## Most influential descendants
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own

## Indications for use
MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Source page: https://510kreport.com/device/K140462
Methodology: https://510kreport.com/methodology