510(k) · Cleared
ClearedLeforte System Bone Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · JEY Plate, Bone
Cleared on Oct 2, 2009 as substantially equivalent to K042365 (Synthes (Usa), 2004) after a 115-day review. Its family tree reaches back 1 generation to 2004. 29 later devices descend from it.
- Decided
- Oct 2, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042365 (2004). 29 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK042365 Synthes (Usa) Neuro Plate and Screw SystemSynthes (Usa) · 2004 · Recalled
- This deviceK091679 Leforte System Bone PlateJeil Medical Corporation · 2009
- Descendant · cites it directly · 16 of its ownK112457 Leforte System Bone Plate & ScrewArkin Consulting Group · 2012
- Descendant · cites it directly · 11 of its ownK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- Descendant · 2 generations on · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
- Descendant · 3 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
- Descendant · 4 generations on · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K112457Leforte System Bone Plate & ScrewArkin Consulting Group · 2012 · cites it directly16descendants
- K112812Leforte Neuro System Bone PlateJeil Medical Corporation · 2012 · cites it directly11descendants
- K131311Arix Foot SystemJeil Medical Corporation · 2013 · 2 generations on9descendants
- K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 3 generations on5descendants
- K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042365 | Synthes (Usa) Neuro Plate and Screw System | Synthes (Usa) | 2004 | 1 |
| 0 (this device) | K091679 | Leforte System Bone Plate | Jeil Medical Corporation | 2009 | — |
| +1 | K112457 | Leforte System Bone Plate & Screw | Arkin Consulting Group | 2012 | — |
| +1 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| +2 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| +3 | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
| +4 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K042365 | Synthes (Usa) Neuro Plate and Screw SystemSummary page 1…5. Equivalent Legally Marketed Device 1) Plate, Bone (Model: Synthes (USA) Neuro Plate and Screw System) manufactured by Synthes (USA) - K042365, Decision Date: 11/18/2004, JEY (Class II per regulation 21CRF 872.4760)… | 2004 |
What descends from it? (29)
See all 293 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. 2009, 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?
This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091679 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091679: Leforte System Bone Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091679
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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