# K073461: Ortho Anchor Screws

- Pathway: 510(k) (Traditional)
- Applicant: Mis Implants Technologies, Ltd.
- Decided: Jan 25, 2008 after 46 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: 5 generations back to K894844 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033767: Dual Top Anchor System Screws, Jeil Medical Corporation (2004) Summary page 2.

## Indications for use
The Ortho Anchor Screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treautent has been completed. The screws are intended for single use only.

Source page: https://510kreport.com/device/K073461
Methodology: https://510kreport.com/methodology
