# K152297: OBS Anchorage Screw

- Pathway: 510(k) (Traditional)
- Applicant: Bomei Co, Ltd.
- Decided: Feb 9, 2016 after 180 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: 9 generations back to K894844 (1990). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090476: Syntec Orthodontic Mini Screw, Syntec Scientific Corp. (2009) Summary page 4.

## Most influential descendants
- K202278: OBS Anchorage Screw, Biokey Anchorage Screw (2021), 0 descendants of its own

## 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/K152297
Methodology: https://510kreport.com/methodology
