# K080744: HG II Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Jul 17, 2008 after 122 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). 18 ancestors in all.
112 later devices descend from it; 2 cite it directly.
0 of 131 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.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 1.

## Most influential descendants
- K082213: GS Iii Fixture System (2008), 110 descendants of its own
- K093352: HG Iii Fixture System (2009), 105 descendants of its own
- K101096: HT Iii SA Fixture System (2010), 104 descendants of its own
- K120847: ET/SS Implant System (2012), 75 descendants of its own
- K121585: TS Implant System (2013), 64 descendants of its own

## Indications for use
The HG II 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.

Source page: https://510kreport.com/device/K080744
Methodology: https://510kreport.com/methodology