# K040469: The Straumann Ortho Implant System

- Pathway: 510(k) (Traditional)
- Applicant: The Straumann Co.
- Decided: Apr 30, 2004 after 66 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: 3 generations back to K894844 (1990). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 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.

## Most influential descendants
- K060062: Straumann Orthosystem (2006), 1 descendant of its own
- K072917: JJG Evolution Orthodontic Implant System (2008), 0 descendants of its own

## Indications for use
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. Ortho implants can be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the midline in the paramedian region of the palate in order to avoid the mid-palatal suture.

Source page: https://510kreport.com/device/K040469
Methodology: https://510kreport.com/methodology