510(k) · Cleared
ClearedMatrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jun 13, 2014 as substantially equivalent to K123723 (Synthes, 2013) after a 109-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jun 13, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022012 (2002). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK022012 Synthes Low Profile Neuro SystemSynthes (Usa) · 2002
- 1 generation backK123723 Synthes Matrixneuro Cranial Plating SystemSynthes · 2013
- This deviceK140462 Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating…Synthes (USA) Products, LLC · 2014
- Descendant · cites it directly · 0 of its ownK192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022012 | Synthes Low Profile Neuro System | Synthes (Usa) | 2002 | — |
| −1 | K123723 | Synthes Matrixneuro Cranial Plating System | Synthes | 2013 | — |
| 0 (this device) | K140462 | Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System) | Synthes (USA) Products, LLC | 2014 | — |
| +1 | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWO device
- #1 K261058 CraniUS Platescore 16.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123723 | Synthes Matrixneuro Cranial Plating SystemSummary page 1…Preformed, Alterable cranioplast plate Predicate Devices Synthes MatrixNEURO Cranial Plating System (K 123723) Indications for Use MatrixNlSURO Preformed Mesh is intended for use in fixation of the cranial bones in proc… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K192702 (Synthes (USA) Products, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123723.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140462: Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140462
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026