510(k) · Cleared
ClearedMedicon 2.4 Mandibular Reconstruction Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicon EG · JEY Plate, Bone
Cleared on Feb 23, 2005 as substantially equivalent to K951689 (Medicon EG, 1995) after an 86-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Feb 23, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951689 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951689 Titanium Mandibulat Reconstruction SystemMedicon EG · 1995
- This deviceK043297 Medicon 2.4 Mandibular Reconstruction Plating SystemMedicon EG · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951689 | Titanium Mandibulat Reconstruction System | Medicon EG | 1995 | — |
| 0 (this device) | K043297 | Medicon 2.4 Mandibular Reconstruction Plating System | Medicon EG | 2005 | — |
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 |
|---|---|---|---|
| * | K951689 | Titanium Mandibulat Reconstruction SystemSummary page 2…The Medicon 2.4 Mandibular Reconstruction Plating System is substantially equivalent to the previously cleared Medicon Titanium Mandibular Reconstruction System (K951689), with the following modifications: a) Plates * Change in material from titanium alloy to titanium · Thickness in… | 1995 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043297: Medicon 2.4 Mandibular Reconstruction 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/K043297
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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