# K113650: Orthofix Screw

- Pathway: 510(k) (Traditional)
- Applicant: Bonafix Surgical and Dental Implants, LLC
- Decided: Oct 3, 2012 after 296 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: 6 generations back to K894844 (1990). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093299: Synthes Orthodontic Bone Anchor System, Synthes (Usa) (2010) Summary page 1.
- K033767: Dual Top Anchor System Screws, Jeil Medical Corporation (2004) Summary page 1.

## Most influential descendants
- K201919: Blue Sky Bio TAD (2020), 0 descendants of its own

## Indications for use
The proposed OrthoFix Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.

Source page: https://510kreport.com/device/K113650
Methodology: https://510kreport.com/methodology