510(k) · Cleared
ClearedLeforte System Bone Plate & Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkin Consulting Group · JEY Plate, Bone
Cleared on May 18, 2012 as substantially equivalent to K091679 (Jeil Medical Corporation, 2009) and 2 other predicates after a 266-day review. Its family tree reaches back 4 generations to 1996. 16 later devices descend from it.
- Decided
- May 18, 2012
- Review
- 266 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953806 (1996). 7 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 3 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 2 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 1 generation backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- This deviceK112457 Leforte System Bone Plate & ScrewArkin Consulting Group · 2012
- Descendant · cites it directly · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
- Descendant · 2 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
- Descendant · 3 generations on · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
- Descendant · 2 generations on · 4 of its ownK170780 ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K131311Arix Foot SystemJeil Medical Corporation · 2013 · cites it directly9descendants
- K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 2 generations on5descendants
- K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · 3 generations on4descendants
- K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017 · 2 generations on4descendants
- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −3 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −2 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −1 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| 0 (this device) | K112457 | Leforte System Bone Plate & Screw | Arkin Consulting Group | 2012 | — |
| +1 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| +2 | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
| +3 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
| +2 | K170780 | ARIX Foot System (2.3/2.8) | Jeil Medical Corporation | 2017 | — |
| +3 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K091679 | Leforte System Bone PlateSummary page 1…Screw, Fixation, Intraosseous 3. Predicate Devices: * Jeil Medical Corporation/ LeForte Neuro System Bane Plate /K091679 * Jeil Medical Corporation/ LeForte Neuro System Bone Plate /K1 03778 *Jeil Medical Corporation/ Le… | 2009 |
| * | K103778 | Leforte Neuro System Bone PlateSummary page 1…Devices: * Jeil Medical Corporation/ LeForte Neuro System Bane Plate /K091679 * Jeil Medical Corporation/ LeForte Neuro System Bone Plate /K1 03778 *Jeil Medical Corporation/ LeForte Neuro System Bone Screw / K(091686 4. Regulatory Classifica… | 2011 |
| * | K091686 | Leforte Neurosystem Bone ScrewSummary page 1…091679 * Jeil Medical Corporation/ LeForte Neuro System Bone Plate /K1 03778 *Jeil Medical Corporation/ LeForte Neuro System Bone Screw / K(091686 4. Regulatory Classifications, Product Code: 21 CFR 872.4760, JEY, Bone Plate, Class 2… | 2009 |
What descends from it? (16)
See all 165 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K131311 (Jeil Medical Corporation, 2013) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K091679.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112457: Leforte System Bone Plate & Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112457
Report an extraction error
Are you the manufacturer?
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