510(k) · Cleared
ClearedMedCAD® AccuPlate® Patient-Specific Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Feb 12, 2021 as substantially equivalent to K122647 (Synthes, Inc., 2013) after a 443-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Feb 12, 2021
- Review
- 443 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063790 (2007). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063790 | The Synthes Matrixmandible Plate and Screw System | Synthes (Usa) | 2007 | — |
| −1 | K122647 | Synthes Patient Specific Plate | Synthes, Inc. | 2013 | — |
| 0 (this device) | K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K122647 | Synthes Patient Specific PlateSummary page 4…Plate Regulation Name: Bone Plate Regulation Number: 872.4760 Product Code: Primary – JEY Classification Panel: Dental Predicate Device Synthes Patient-Specific Plates (K122647) Reference Devices Stryker Customized Mandible Recon Plate Kit (K132519) Biomet Fracture/Reconstruction System Trauma One (K0810… | 2013 |
| † | K132519 | Stryker Customized Mandible Recon Plate Kit | 2013 |
| † | K081067 | Fracture/Reconstruction System (Traumaone) | 2008 |
| † | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K122647.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription 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/K193280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193280: MedCAD® AccuPlate® Patient-Specific Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193280
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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