# K161335: Dual Top Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Feb 23, 2017 after 287 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: 10 generations back to K894844 (1990). 26 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063495: C Type, CT Type, and Special Type Orthodontic Anchor Screws, Biomaterials Korea, Inc. (2007) Summary page 5.
- K110392: PSM Lomas / Benefit Screws, Psm Medical Solutions (2011) Summary page 5.

## Most influential descendants
- K231913: T-FIT (2024), 0 descendants of its own
- K210559: ATOZ Mini-Screw (2021), 0 descendants of its own
- K191041: Orthodontic Fixation Screw [Smart Anchor Miniscrew] (2020), 0 descendants of its own

## Indications for use
The Dual Top Screw System 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/K161335
Methodology: https://510kreport.com/methodology