510(k) Report

510(k) · Cleared

Cleared

Synthes Matrixneuro Cranial Plating System

K123723510(k) TraditionalCleared Sep 5, 2013275-day reviewClass II21 CFR 882.5320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes · GWO Plate, Cranioplasty, Preformed, Alterable

Cleared on Sep 5, 2013 as substantially equivalent to K042365 (Synthes (Usa), 2004) and 3 other predicates after a 275-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.

Decided
Sep 5, 2013
Review
275 days
Class
Class II
Product code
GWO
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K022012 (2002). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 2 other ancestors2014: 1 descendant cleared2020: 1 descendant clearedK022012 · Synthes Low Profile Neuro System · Synthes (Usa) · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants K022012 · Synthes Low Profile Neuro System · Synthes (Usa) · 20020
  1. Root · 1 generation backK022012 Synthes Low Profile Neuro SystemSynthes (Usa) · 2002
  2. This deviceK123723 Synthes Matrixneuro Cranial Plating SystemSynthes · 2013
  3. Descendant · cites it directly · 1 of its ownK140462 Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating…Synthes (USA) Products, LLC · 2014
  4. Descendant · cites it directly · 0 of its ownK192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K140462Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)Synthes (USA) Products, LLC · 2014 · cites it directly1descendant
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K022012Synthes Low Profile Neuro SystemSynthes (Usa)2002—
0 (this device)K123723Synthes Matrixneuro Cranial Plating SystemSynthes2013—
+1K140462Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)Synthes (USA) Products, LLC2014—
+1K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
202010
FIG. 1 — Lineage of K123723, 2002–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261058 CraniUS Platescore 16.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042365Synthes (Usa) Neuro Plate and Screw System
Summary page 1
…Sjtp 052013 Secondary Product Codes / Regulation Numbers GXR/ 21 CFR 882.5250 Predicate Devices * Synthes Neuro Plate and Screw System (K042365) * Synthes Low Profile Contourable Mesh Plates (K033 160) * Synthes Low Profile Neuro Plate and Screw System (K03 1807) * S…
Synthes (Usa)20041
*K033160Synthes Sterile Low Profile Neuro Contourable Mesh Plates
Summary page 1
…Codes / Regulation Numbers GXR/ 21 CFR 882.5250 Predicate Devices * Synthes Neuro Plate and Screw System (K042365) * Synthes Low Profile Contourable Mesh Plates (K033 160) * Synthes Low Profile Neuro Plate and Screw System (K03 1807) * Synthes Low Profile Neuro Plate and Screw System (K022012)…
Synthes (Usa)2003—
*K031807Synthes Low Profile Neuro System - 3 MM Screws
Summary page 1
…ices * Synthes Neuro Plate and Screw System (K042365) * Synthes Low Profile Contourable Mesh Plates (K033 160) * Synthes Low Profile Neuro Plate and Screw System (K03 1807) * Synthes Low Profile Neuro Plate and Screw System (K022012) Indications for Use The Synthes MatrixNEURO Cranial Plating Sys…
Synthes (Usa)20032
*K022012Synthes Low Profile Neuro System
Summary page 1
…thes Low Profile Contourable Mesh Plates (K033 160) * Synthes Low Profile Neuro Plate and Screw System (K03 1807) * Synthes Low Profile Neuro Plate and Screw System (K022012) Indications for Use The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in pro…
Synthes (Usa)2002—

Also cleared against K042365: 4 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140462Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)Synthes (USA) Products, LLC20141
K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200

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?

  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K140462 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K042365.

How does its category compare?

All GWO devices

GWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GWO

2in 2025

2007: 12008: 12010: 12011: 22012: 52013: 42014: 32015: 32016: 32017: 22018: 12019: 42021: 12022: 22024: 12025: 22026 (partial year): 2
2007high 5 (2012) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWO

196in 2019

2012: 133 days median2013: 249 days median2014: 109 days median2015: 210 days median2016: 125 days median2019: 196 days median
2007high 249 (2013) · low 109 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWO

2in 2015

2007: 12015: 2
2007high 2 (2015) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWO

237in 2025

2008: 32009: 22010: 72011: 12012: 52013: 72014: 112015: 182016: 182017: 472018: 412019: 142020: 252021: 412022: 532023: 722024: 1492025: 237
2007high 237 (2025) · low 0 (2007)2025

MAUDE reports naming product code GWO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—10
20081—03
20090—02
20101—07
20112—01
2012513305
2013424907
20143109011
20153210218
20163125018
20172—047
20181—041
20194196014
20200—025
20211—041
20222—053
20230—072
20241—0149
20252—0237
20262—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K042365

4 other devices cite the same predicate.

  • K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
  • K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
  • K091686Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
  • K091679Leforte System Bone PlateJeil Medical Corporation · 2009

More from Synthes

11 FDA decisions under this applicant name. See the company

  • K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 20132 recalls
  • K113071Synthecel Dura Replacement DevicesSynthes · 20125 recalls
  • K110604VBB SystemSynthes · 20111 recall
  • K093772Synthes Sternal Fixation SystemSynthes · 2010
  • K013072Chronos Tricalcium Prosphate (Chronos TCP)Synthes · 2002

Recent decisions in GWO

The GWO category page

  • K262874CraniUS PlateCraniUS, LLC · 2026
  • K261058CraniUS PlateCraniUS, LLC · 2026
  • K250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc. · 2025
  • K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc. · 2025
  • K231834VSP PEEK Cranial Implant3D Systems, Inc. · 2024

https://510kreport.com/device/K123723 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123723: Synthes 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/K123723

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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