# K091679: Leforte System Bone Plate

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Oct 2, 2009 after 115 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: 1 generation back to K042365 (2004). 1 ancestor in all.
29 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042365: Synthes (Usa) Neuro Plate and Screw System, Synthes (Usa) (2004) Summary page 1.

## 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

## Indications for use
This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K091679
Methodology: https://510kreport.com/methodology