# K181854: OssBuilder System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: May 7, 2019 after 300 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894595 (1990). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160991: Neo GBR System, Neobiotech Co., Ltd. (2017) Summary page 4.
- K172354: OssBuilder System, Osstem Implant Co., Ltd. (2018) Summary page 4.

## Indications for use
The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.

Source page: https://510kreport.com/device/K181854
Methodology: https://510kreport.com/methodology