# K252246: Leforte MMF System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Apr 2, 2026 after 258 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K954385 (1996). 238 ancestors in all.
No later device cites it as a predicate yet.
0 of 239 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122313: Stryker Universal Smartlock Hybrid MMF System, Stryker (2012) Summary page 5.
- K112457: Leforte System Bone Plate & Screw, Arkin Consulting Group (2012) Summary page 5.
- K231887: ARIX Ankle Distal Tibia System, Jeil Medical Corporation (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K252246
Methodology: https://510kreport.com/methodology