# K103778: Leforte Neuro System Bone Plate

- Pathway: 510(k) (Special)
- Applicant: Jeil Medical Corporation
- Decided: Jan 26, 2011 after 30 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
No predicates in its family tree.
29 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K112457: Leforte System Bone Plate & Screw (2012), 16 descendants of its own
- K112812: Leforte Neuro System Bone Plate (2012), 11 descendants of its own
- K131311: Arix Foot System (2013), 9 descendants of its own
- K161864: ARIX Foot System (2016), 5 descendants of its own
- K172260: Omni Foot Plating System (2017), 4 descendants of its own

Source page: https://510kreport.com/device/K103778
Methodology: https://510kreport.com/methodology