# K172354: OssBuilder System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Mar 26, 2018 after 235 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: 11 generations back to K894595 (1990). 30 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120951: Smartbuilder System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K140600: SB Anchor, Osstem Implant Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K222451: Save GBR (2023), 0 descendants of its own
- K192747: Yxoss CBR® (2020), 0 descendants of its own
- K181854: OssBuilder System (2019), 0 descendants of its own

## Indications for use
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Source page: https://510kreport.com/device/K172354
Methodology: https://510kreport.com/methodology