# K191041: Orthodontic Fixation Screw [Smart Anchor Miniscrew]

- Pathway: 510(k) (Traditional)
- Applicant: Gni Co., Ltd.
- Decided: Aug 28, 2020 after 497 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: 11 generations back to K894844 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161335: Dual Top Screw System, Jeil Medical Corporation (2017) Summary page 4.

## Indications for use
The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.

Source page: https://510kreport.com/device/K191041
Methodology: https://510kreport.com/methodology