510(k) · Cleared
ClearedLeforte MMF System
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 Apr 2, 2026 as substantially equivalent to K122313 (Stryker, 2012) and 2 other predicates after a 258-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Apr 2, 2026
- Review
- 258 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K954385 (1996). 238 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- 2 generations backK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- 1 generation backK231887 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023
- This deviceK252246 Leforte MMF SystemJeil Medical Corporation · 2026
Show all 16 generations
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 15 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 14 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 13 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 12 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 11 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 10 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 9 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 8 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 7 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 6 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 3 generations backK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- 2 generations backK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- 1 generation backK231887 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023
- This deviceK252246 Leforte MMF SystemJeil Medical Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −15 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −14 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −13 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −12 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −11 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −10 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −9 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −8 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −7 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −6 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −3 | K160191 | Align Anterior Ankle Fusion Plate | Extremity Medical, LLC | 2016 | — |
| −2 | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | — |
| −1 | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | — |
| 0 (this device) | K252246 | Leforte MMF System | Jeil Medical Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 18 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 12 | 0 |
| 2001 | 20 | 0 |
| 2002 | 20 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 17 | 0 |
| 2006 | 15 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 11 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 K210731 KLS Martin Individual Patient Solutionsscore 14.2 · 6 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 |
|---|---|---|---|
| * | K122313 | Stryker Universal Smartlock Hybrid MMF SystemSummary page 5…Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)] Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K122313 Stryker Universal SMARTLock Hybrid MMF System JEY K112457 LeForte System B… | 2012 |
| * | K112457 | Leforte System Bone Plate & ScrewSummary page 5…imary Predicate is listed first) Product Code K122313 Stryker Universal SMARTLock Hybrid MMF System JEY K112457 LeForte System Bone Plate & Screw JEY K231887 ARIX Ankle Dista… | 2012 |
| * | K231887 | ARIX Ankle Distal Tibia SystemSummary page 5…al SMARTLock Hybrid MMF System JEY K112457 LeForte System Bone Plate & Screw JEY K231887 ARIX Ankle Distal Tibia System HRS… | 2023 |
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 30 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 34 of the 238 ancestors have a recall of any class.
- 4 other devices also cite its predicate K122313.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
The Leforte MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252246: Leforte MMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252246
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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