510(k) · Cleared
ClearedMedCAD® AccuPlate® 3DTi Patient-Specific Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Sep 26, 2023 as substantially equivalent to K191028 (KLS-Martin L.P., 2019) after a 222-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Sep 26, 2023
- Review
- 222 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954385 (1996). 14 ancestors in all, the oldest K943347 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 4 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 3 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 2 generations backK163579 KLS Martin Individual Patient SolutionsKLS Martin L.P. · 2017
- 1 generation backK191028 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2019
- This deviceK230398 MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −5 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −4 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −3 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −2 | K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017 | — |
| −1 | K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019 | — |
| 0 (this device) | K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K191028 | KLS Martin Individual Patient SolutionsSummary page 5…ation Name: Bone Plate (21 CFR 872.4760) Code – Regulatory Class: II Classification Product Code: JEY Primary K191028 KLS Martin Individual Patient Solutions Predicate K953385 Walter Lorenz Surgical, Inc. Lorenz System… | 2019 |
| † | K953385 | Lorenz 1.0MM, 1.5MM, 2.0MM System | 1995 |
| † | K210731 | KLS Martin Individual Patient Solutions | 2022 |
| † | K203282 | TECHFIT Patient-Specific Maxillofacial System | 2021 |
| † | K170272 | TruMatch CMF Titanium 3D Printed Implant System | 2017 |
| † | K192282 | MedCAD® AccuPlan® System | 2020 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 2 other devices also cite its predicate K191028.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230398: MedCAD® AccuPlate® 3DTi Patient-Specific 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/K230398
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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