# K080387: HU II / HS II Fixture System

- Pathway: 510(k) (Special)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Mar 7, 2008 after 23 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). 17 ancestors in all.
77 later devices descend from it; 3 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062030: US System, Osstem Implant Co., Ltd. (2006) Summary page 1.
- K062051: SS System, Osstem Implant Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K083633: HS II Short Fixture System (2009), 76 descendants of its own
- K120847: ET/SS Implant System (2012), 75 descendants of its own
- K130662: ET Prosthetic System (2014), 42 descendants of its own
- K161689: OSSTEM Implant System - Abutment (2017), 38 descendants of its own
- K160670: ET US SS Prosthetic system (2017), 32 descendants of its own

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

Source page: https://510kreport.com/device/K080387
Methodology: https://510kreport.com/methodology