# K100245: HS/HG Prosthetic System

- Pathway: 510(k) (Special)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Aug 17, 2010 after 202 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 26 ancestors in all.
111 later devices descend from it; 4 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 1.
- K081786: Ziocera & Convertible System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K110308: Prosthetic System (2011), 105 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
- K123755: Multi Angled Abutment (2013), 47 descendants of its own
- K140507: Hiossen Prosthetic System (2014), 44 descendants of its own

## Indications for use
HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Source page: https://510kreport.com/device/K100245
Methodology: https://510kreport.com/methodology