# K060062: Straumann Orthosystem

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: Feb 3, 2006 after 25 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894844 (1990). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 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.
- K040469: The Straumann Ortho Implant System, The Straumann Co. (2004) Summary page 1.
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 1.

## Most influential descendants
- K072917: JJG Evolution Orthodontic Implant System (2008), 0 descendants of its own

## Recalls of this device
- Sep 28, 2007 · Not classified · Z-0277-2008: Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
- Sep 28, 2007 · Not classified · Z-0278-2008: Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.

## Indications for use
The Straumann Palatal implant is 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 the 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. Palatal 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 palatal implants shouid be placed off the mid-line in the paramedian region of the palate in order to avoid the mid-palatal suture.

Source page: https://510kreport.com/device/K060062
Methodology: https://510kreport.com/methodology