510(k) · Cleared
ClearedLeForte System II
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 Sep 17, 2015 as substantially equivalent to K112457 (Arkin Consulting Group, 2012) after a 160-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Sep 17, 2015
- Review
- 160 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953806 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 4 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 3 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 2 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 1 generation backK112457 Leforte System Bone Plate & ScrewArkin Consulting Group · 2012
- This deviceK150965 LeForte System IIJeil Medical Corporation · 2015
- Descendant · cites it directly · 0 of its ownK182609 Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019
Most influential descendants
Showing 1 of 1 · See all- K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −4 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −3 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −2 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −1 | K112457 | Leforte System Bone Plate & Screw | Arkin Consulting Group | 2012 | — |
| 0 (this device) | K150965 | LeForte System II | Jeil Medical Corporation | 2015 | — |
| +1 | K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019 | — |
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 |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K112457 | Leforte System Bone Plate & ScrewSummary page 4…• Device Class: II 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] Primary Predicate Device: • 510(k) Number : K112457 • Applicant: Jeil Medical Corporat ion • Common Name: Bone plates and screws • De… | 2012 |
| † | K080694 | Osteomed Modular Locking Fixation System | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182609 | Delphos Implants Rigid Fixation System | 2019 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K182609 (Delphos Implants - Ind.Com. Importacao E Exportacao DE, 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K112457.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 LeForte System II is intended for use in selective trauma of mid-face, reconstruction procedure and selective orthognathic surgery of the maxilla and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150965: LeForte System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150965
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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