# K163088: TSIII BA Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Apr 21, 2017 after 168 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: 14 generations back to K894595 (1990). 153 ancestors in all.
No later device cites it as a predicate yet.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151626: ET III Bio-SA Fixture System, Hiossen, Inc. (2016) Summary page 4.
- K121995: TS Fixture System, Osstem Implant Co., Ltd. (2012) Summary page 4.

## Indications for use
TSIII BA Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Source page: https://510kreport.com/device/K163088
Methodology: https://510kreport.com/methodology