# K083633: HS II Short Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: May 1, 2009 after 144 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). 26 ancestors in all.
76 later devices descend from it; 2 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080387: HU II / HS II Fixture System, Osstem Implant Co., Ltd. (2008) Summary page 1.
- K033922: Modification to Iti Dental Implant System, Institut Straumann AG (2004) Summary page 1.

## Most influential descendants
- 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
- K182091: Osstem Abutment System (2019), 30 descendants of its own

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

Source page: https://510kreport.com/device/K083633
Methodology: https://510kreport.com/methodology