510(k) · Cleared
ClearedSynthes Patient Specific Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes, Inc. · JEY Plate, Bone
Cleared on Feb 28, 2013 as substantially equivalent to K063790 (Synthes (Usa), 2007) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 2007. 5 later devices descend from it.
- Decided
- Feb 28, 2013
- Review
- 182 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K063790 (2007). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK063790 The Synthes Matrixmandible Plate and Screw SystemSynthes (Usa) · 2007
- This deviceK122647 Synthes Patient Specific PlateSynthes, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK132519 Stryker Customized Mandible Recon Plate KitStryker · 2013
- Descendant · 2 generations on · 1 of its ownK193136 Stryker Customized Mandible Recon Plate KitStryker · 2020
- Descendant · 3 generations on · 0 of its ownK222650 Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible…Stryker Craniomaxillofacial (Cmf) · 2022
- Descendant · cites it directly · 0 of its ownK193280 MedCAD® AccuPlate® Patient-Specific PlateMedcad · 2021
- Descendant · 2 generations on · 0 of its ownK190696 Stryker Surgeon iD Mandible Recon PlateStryker · 2019
Most influential descendants
Showing 5 of 5 · See all- K132519Stryker Customized Mandible Recon Plate KitStryker · 2013 · cites it directly3descendants
- K193136Stryker Customized Mandible Recon Plate KitStryker · 2020 · 2 generations on1descendant
- K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf) · 2022 · 3 generations on0descendants
- K193280MedCAD® AccuPlate® Patient-Specific PlateMedcad · 2021 · cites it directly0descendants
- K190696Stryker Surgeon iD Mandible Recon PlateStryker · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063790 | The Synthes Matrixmandible Plate and Screw System | Synthes (Usa) | 2007 | — |
| 0 (this device) | K122647 | Synthes Patient Specific Plate | Synthes, Inc. | 2013 | — |
| +1 | K132519 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2013 | — |
| +2 | K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2020 | — |
| +3 | K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | 2022 | — |
| +1 | K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | 2021 | — |
| +2 | K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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…21 CFR 872.4760 Product Code JEY Common Name: Bone Plate Predicate Devices * Synthes MatrixMAND1BLE Plating System (K063790) * Synthes MatrixMANDIBLE Preformed Reconstruction Plates (K091 144) Indications for Use Synthes Patient Specific Plates ar… | 2007 |
| * | K091144 | Synthes Matrixmandible Preformed Reconstruction PlatesSummary page 1…e: Bone Plate Predicate Devices * Synthes MatrixMAND1BLE Plating System (K063790) * Synthes MatrixMANDIBLE Preformed Reconstruction Plates (K091 144) Indications for Use Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery, trauma and reconst… | 2009 |
What descends from it? (5)
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?
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery,
trauma and reconstructive surgery.
Specific Indications for Use:
Primary mandibular reconstruction with bone graft
Temporary bridging until delayed secondary reconstruction
Secondary mandibular reconstruction
Comminuted mandibular fractures
Fractures of edentulous and/or atrophic mandibles
Unstable mandibular fractures
Maxillary reconstruction with or without bone graft
Maxillary trauma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122647: Synthes Patient Specific Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122647
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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