# K161197: Orthodontic Screw

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Dec 21, 2016 after 237 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- 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: 7 generations back to K894844 (1990). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103105: Orthodontic Screw, Osstem Implant Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K231502: Mini Screws (2024), 0 descendants of its own
- K190871: Bio-TackS Orthodontic Mini Implant (2020), 0 descendants of its own

## Indications for use
The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only

Source page: https://510kreport.com/device/K161197
Methodology: https://510kreport.com/methodology