# K143730: GBR System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Jun 10, 2015 after 163 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: 6 generations back to K894844 (1990). 40 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050669: Jeil Bone Fixation System, Jeil Medical Corporation (2005) Summary page 4.

## Most influential descendants
- K160991: Neo GBR System (2017), 1 descendant of its own
- K181854: OssBuilder System (2019), 0 descendants of its own

## Indications for use
The GBR System is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

Source page: https://510kreport.com/device/K143730
Methodology: https://510kreport.com/methodology