# K091208: GS Iii System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Mar 3, 2010 after 313 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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 K894595 (1990). 28 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082213: GS Iii Fixture System, Osstem Implant Co., Ltd. (2008) Summary page 1.
- K081786: Ziocera & Convertible System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K121995: TS Fixture System (2012), 24 descendants of its own
- K153521: IH Implant System (2016), 10 descendants of its own
- K172100: URIS OMNI System (2018), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K222778: Osstem Implant System (2023), 2 descendants of its own

## Indications for use
The GSIII System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The GS II System is for single and two stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K091208
Methodology: https://510kreport.com/methodology