# K090237: HG II Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Apr 17, 2009 after 74 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: 8 generations back to K894595 (1990). 19 ancestors in all.
38 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080744: HG II Fixture System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K121995: TS Fixture System (2012), 24 descendants of its own
- K123471: Etii SA Fixture System (2013), 14 descendants of its own
- K140934: Hiossen Implant System (2014), 13 descendants of its own
- K153521: IH Implant System (2016), 10 descendants of its own
- K151626: ET III Bio-SA Fixture System (2016), 9 descendants of its own

## Indications for use
The HG TI 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. The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K090237
Methodology: https://510kreport.com/methodology