# K121995: TS Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Nov 29, 2012 after 143 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: 12 generations back to K894595 (1990). 46 ancestors in all.
24 later devices descend from it; 11 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090237: HG II Fixture System, Hiossen, Inc. (2009) Summary page 1.
- K101096: HT Iii SA Fixture System, Hiossen, Inc. (2010) Summary page 1.
- K091208: GS Iii System, Osstem Implant Co., Ltd. (2010) Summary page 1.
- K103537: ET Iii SA Ultra Wide System, Hiossen, Inc. (2011) Summary page 1.

## Most influential descendants
- K153521: IH Implant System (2016), 10 descendants of its own
- K172100: URIS OMNI System (2018), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K222778: Osstem Implant System (2023), 2 descendants of its own
- K242753: SD TL Implant System (2025), 1 descendant of its own

## Indications for use
The TS 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. TS Fixture System is compatible with abutment in the ET/SS Implant System

Source page: https://510kreport.com/device/K121995
Methodology: https://510kreport.com/methodology