# K122069: Storm Mini Screw

- Pathway: 510(k) (Traditional)
- Applicant: Lancer Orthodontics, Inc.
- Decided: Apr 11, 2013 after 269 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: 8 generations back to K894844 (1990). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071851: HDC Sterile Spider Screw, Hdc S.R.L. (2007) Summary page 1.
- K063149: Orthodontic Taads (Temporary Anatomical Anchor Device System), T.O.a.D.S., LLC (2007) Summary page 1.

## Indications for use
The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth, It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.

Source page: https://510kreport.com/device/K122069
Methodology: https://510kreport.com/methodology