# K081575: HU/HS/HG Prosthetic System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 2, 2008 after 89 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: 8 generations back to K894595 (1990). 19 ancestors in all.
129 later devices descend from it; 10 cite it directly.
0 of 149 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.
- K063861: GS System, Osstem Implant Co., Ltd. (2007) Summary page 1.
- K073247: US/SS/GS System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K100245: HS/HG Prosthetic System (2010), 111 descendants of its own
- 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
- K121843: NP-Cast Abutment System (2012), 54 descendants of its own

## Indications for use
HU/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/K081575
Methodology: https://510kreport.com/methodology