# K202278: OBS Anchorage Screw, Biokey Anchorage Screw

- Pathway: 510(k) (Special)
- Applicant: Bomei Co, Ltd.
- Decided: Jan 8, 2021 after 150 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: 10 generations back to K894844 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152297: OBS Anchorage Screw, Bomei Co, Ltd. (2016) Summary page 5.

## Indications for use
Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Source page: https://510kreport.com/device/K202278
Methodology: https://510kreport.com/methodology