# K050568: Orlus Mini Screw

- Pathway: 510(k) (Traditional)
- Applicant: Ortholution Co., Ltd.
- Decided: Jun 1, 2005 after 89 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- 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: 4 generations back to K894844 (1990). 15 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031936: Osteomed Orthodontic Screw System, Osteomed LP (2004) Summary page 1.
- (no number) Dual Top Anchor System Screws: named in the summary without a submission number

## Most influential descendants
- K052968: Modification to: Orlus Mini Screw (2006), 2 descendants of its own
- K082838: Orlus Mini Screw (2008), 1 descendant of its own
- K062367: Miniscrews Anchoring System, M.a.S. (2006), 1 descendant of its own
- K102769: Neodent Implant for Orthodontic Anchorage (2011), 0 descendants of its own
- K072917: JJG Evolution Orthodontic Implant System (2008), 0 descendants of its own

## Indications for use
The Orlus Mini Screw is intended for use as a temporary anchor for orthodontic treatment.

Source page: https://510kreport.com/device/K050568
Methodology: https://510kreport.com/methodology