# K091678: HG II Short Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Feb 18, 2010 after 253 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
No predicates in its family tree.
66 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121585: TS Implant System (2013), 64 descendants of its own
- K140507: Hiossen Prosthetic System (2014), 44 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 HG II Short Fixture System is indicated for use in partially or filly 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 Short Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K091678
Methodology: https://510kreport.com/methodology