# K163557: SS SA Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: May 15, 2017 after 147 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.
3 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K222778: Osstem Implant System (2023), 2 descendants of its own
- K242753: SD TL Implant System (2025), 1 descendant of its own
- K250280: SD TL Implant System (2025), 0 descendants of its own

## Indications for use
The Osstem Implant 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. Ultra Wide Fixture System is intended to be used in the molar region.

Source page: https://510kreport.com/device/K163557
Methodology: https://510kreport.com/methodology