# K231913: T-FIT

- Pathway: 510(k) (Traditional)
- Applicant: Techwin Co., Ltd.
- Decided: Feb 8, 2024 after 224 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 5.

## Indications for use
The T-FIT is designed to provide a fixed anchorage point for attaching orthodontic appliances, facilitating the orthodontic movement of teeth. It is used temporarily and removed upon completion of the orthodontic treatment for use in patients aged 12 and older. The screws are intended for single use only.

Source page: https://510kreport.com/device/K231913
Methodology: https://510kreport.com/methodology