# K072896: GS Fixture System

- Pathway: 510(k) (Special)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Nov 6, 2007 after 26 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: 7 generations back to K894595 (1990). 17 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063861: GS System, Osstem Implant Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K121047: Hero II Dental Implant System, IS Dental Implant System (2012), 14 descendants of its own
- K131682: UD Implant System (2013), 5 descendants of its own
- K160536: Chaorum Implant System (2017), 3 descendants of its own
- K150060: J2A Dental Implant System, J2C Dental Implant System (2015), 2 descendants of its own
- K161923: J2A SLA Dental Implant System (2017), 1 descendant of its own

## Indications for use
GS fixture 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. GS fixture System is for single and two stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K072896
Methodology: https://510kreport.com/methodology