510(k) · Cleared
ClearedThe Synthes Matrixmandible Plate and Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JEY Plate, Bone
Cleared on Apr 16, 2007 after a 115-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.
- Decided
- Apr 16, 2007
- Review
- 115 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 7 citing it directly.
- This deviceK063790 The Synthes Matrixmandible Plate and Screw SystemSynthes (Usa) · 2007
- Descendant · cites it directly · 5 of its ownK170272 TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK122647 Synthes Patient Specific PlateSynthes, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK113567 Synthes Matrixmadible Plate and Screw SystemSynthes, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK132519 Stryker Customized Mandible Recon Plate KitStryker · 2013
- Descendant · 2 generations on · 2 of its ownK173039 TruMatch CMF Titanium 3D Printed ImplantMaterialise NV · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV · 2017 · cites it directly5descendants
- K122647Synthes Patient Specific PlateSynthes, Inc. · 2013 · cites it directly5descendants
- K113567Synthes Matrixmadible Plate and Screw SystemSynthes, Inc. · 2012 · cites it directly4descendants
- K132519Stryker Customized Mandible Recon Plate KitStryker · 2013 · 2 generations on3descendants
- K173039TruMatch CMF Titanium 3D Printed ImplantMaterialise NV · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063790 | The Synthes Matrixmandible Plate and Screw System | Synthes (Usa) | 2007 | — |
| +1 | K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017 | 2 |
| +1 | K122647 | Synthes Patient Specific Plate | Synthes, Inc. | 2013 | — |
| +1 | K113567 | Synthes Matrixmadible Plate and Screw System | Synthes, Inc. | 2012 | — |
| +2 | K132519 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2013 | — |
| +2 | K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Synthes 2.4 mm Universal Locking Plate System Named without a submission number | |
| * | — | Synthes 2.0 Locking Plate System Named without a submission number | |
| * | — | Synthes Mandibular Modular Fixation System Named without a submission number | |
| * | — | Stryker Leibinger NewGen System Named without a submission number |
What descends from it? (22)
See all 227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170272 | TruMatch CMF Titanium 3D Printed Implant System | 2017 | 5 |
| K122647 | Synthes Patient Specific Plate | 2013 | 5 |
| K113567 | Synthes Matrixmadible Plate and Screw System | 2012 | 4 |
| K080694 | Osteomed Modular Locking Fixation System | 2008 | 2 |
| K121574 | Synthes Matrixmadible Plate and Screw System | 2012 | 1 |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | 2020 | 0 |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | 2019 | 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?
- Of its descendants, K170272 (Materialise NV, 2017) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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; and orthognathic surgery (surgical correction of dentofacial deformities).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063790 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063790: The Synthes Matrixmandible Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063790
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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