# K031936: Osteomed Orthodontic Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Jan 7, 2004 after 198 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: 3 generations back to K894844 (1990). 14 ancestors in all.
63 later devices descend from it; 8 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982509: Ortho Implant and Accessories, Straumann USA (1998) Summary page 1.
- K000643: Inplant Orthodontic Anchor System, Nobel Biocare Uas, Inc. (2000) Summary page 1.

## Most influential descendants
- K033767: Dual Top Anchor System Screws (2004), 54 descendants of its own
- K042965: Tomas Pin (2005), 26 descendants of its own
- K060126: Absoanchor Microimplant (2006), 19 descendants of its own
- K071490: Leone Orthodontic Mini Implant (2008), 14 descendants of its own
- K090476: Syntec Orthodontic Mini Screw (2009), 13 descendants of its own

## Indications for use
Indicated 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 single use only.

Source page: https://510kreport.com/device/K031936
Methodology: https://510kreport.com/methodology