# K063861: GS System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 21, 2007 after 267 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: 6 generations back to K894595 (1990). 16 ancestors in all.
202 later devices descend from it; 10 cite it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062051: SS System, Osstem Implant Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K073247: US/SS/GS System (2008), 141 descendants of its own
- K081575: HU/HS/HG Prosthetic System (2008), 129 descendants of its own
- K081786: Ziocera & Convertible System (2008), 123 descendants of its own
- K080744: HG II Fixture System (2008), 112 descendants of its own
- K100245: HS/HG Prosthetic System (2010), 111 descendants of its own

## Indications for use
GS System is intended 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 System is for one stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K063861
Methodology: https://510kreport.com/methodology