# K131289: I-GEN

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Sep 25, 2013 after 142 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: 3 generations back to K963394 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111761: Neo Titanium Mesh, Cti-Mem, Neobiotech Co., Ltd. (2012)

## Indications for use
i-Gen is a titanium bone plate device intended to stabilization and support bone grafls in dento-alveolar bony defect sites.

Source page: https://510kreport.com/device/K131289
Methodology: https://510kreport.com/methodology