# K112457: Leforte System Bone Plate & Screw

- Pathway: 510(k) (Special)
- Applicant: Arkin Consulting Group
- Decided: May 18, 2012 after 266 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: 4 generations back to K953806 (1996). 7 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091679: Leforte System Bone Plate, Jeil Medical Corporation (2009) Summary page 1.
- K103778: Leforte Neuro System Bone Plate, Jeil Medical Corporation (2011) Summary page 1.
- K091686: Leforte Neurosystem Bone Screw, Jeil Medical Corporation (2009) Summary page 1.

## Most influential descendants
- 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
- K170780: ARIX Foot System (2.3/2.8) (2017), 4 descendants of its own
- K180808: Omni Foot Plating System (2018), 3 descendants of its own

## Indications for use
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K112457
Methodology: https://510kreport.com/methodology