# K150965: LeForte System II

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Sep 17, 2015 after 160 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: 5 generations back to K953806 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112457: Leforte System Bone Plate & Screw, Arkin Consulting Group (2012) Summary page 4.

## Most influential descendants
- K182609: Delphos Implants Rigid Fixation System (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K150965
Methodology: https://510kreport.com/methodology