510(k) · Cleared
ClearedSynthes Matrixmadible Plate and Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes, Inc. · JEY Plate, Bone
Cleared on Nov 19, 2012 as substantially equivalent to K063790 (Synthes (Usa), 2007) and 1 other predicate after a 353-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- Nov 19, 2012
- Review
- 353 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954385 (1996). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 1 generation backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- This deviceK113567 Synthes Matrixmadible Plate and Screw SystemSynthes, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK140037 Optimus CMF SystemOsteonic Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK253373 Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK160363 Optimus CMF SystemOsteonic Co., Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K140037Optimus CMF SystemOsteonic Co., Ltd. · 2015 · cites it directly2descendants
- K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025 · 2 generations on0descendants
- K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
- K160363Optimus CMF SystemOsteonic Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −1 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| 0 (this device) | K113567 | Synthes Matrixmadible Plate and Screw System | Synthes, Inc. | 2012 | — |
| +1 | K140037 | Optimus CMF System | Osteonic Co., Ltd. | 2015 | — |
| +2 | K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty), Ltd. | 2025 | — |
| +1 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
| +2 | K160363 | Optimus CMF System | Osteonic Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K063790 | The Synthes Matrixmandible Plate and Screw SystemSummary page 1…mon Name Bone Plate Classification Name Bone Plate, 21 CFR 872.4760, Product Code JEY Predicate Devices MatrixMANDIBLE Plate and Screw System (K063790) Synthes 2.0 mmn Locking Plate System (K9745 55) Intended Use The Synthes MatrixMANDIBLE plate and scr… | 2007 |
| * | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS)Summary page 1…1 CFR 872.4760, Product Code JEY Predicate Devices MatrixMANDIBLE Plate and Screw System (K063790) Synthes 2.0 mmn Locking Plate System (K9745 55) Intended Use The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery: * Trauma "… | 1998 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140037 (Osteonic Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K063790.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:
* Trauma
* Reconstructive surgery
* Orthogntthic surgery (surgical correction of dento facial deformities)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113567: Synthes Matrixmadible Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113567
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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