# K123723: Synthes Matrixneuro Cranial Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: Sep 5, 2013 after 275 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: 1 generation back to K022012 (2002). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K042365: Synthes (Usa) Neuro Plate and Screw System, Synthes (Usa) (2004) Summary page 1.
- K033160: Synthes Sterile Low Profile Neuro Contourable Mesh Plates, Synthes (Usa) (2003) Summary page 1.
- K031807: Synthes Low Profile Neuro System - 3 MM Screws, Synthes (Usa) (2003) Summary page 1.
- K022012: Synthes Low Profile Neuro System, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- 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 MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotamies.

Source page: https://510kreport.com/device/K123723
Methodology: https://510kreport.com/methodology