# K170697: GBR system

- Pathway: 510(k) (Traditional)
- Applicant: Surgident
- Decided: May 24, 2018 after 443 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: 9 generations back to K761228 (1976). 80 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141764: Tristar Bone Graft Fixation System, Impladent, Ltd. (2014) Summary page 4.
- K050669: Jeil Bone Fixation System, Jeil Medical Corporation (2005) Summary page 4.

## Most influential descendants
- K222367: Save GBR (2023), 0 descendants of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
The device 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. Single patient use only.

Source page: https://510kreport.com/device/K170697
Methodology: https://510kreport.com/methodology