# K063473: Synthes Orthodontic Bone Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 8, 2007 after 112 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 K925771 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033483: KLS-Martin Ortho Anchorage System, KLS-Martin L.P. (2004) Summary page 1.
- K040891: KLS Martin Ortho Anchorage System (Plates), KLS-Martin L.P. (2004) Summary page 1.

## Indications for use
The Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures.

Source page: https://510kreport.com/device/K063473
Methodology: https://510kreport.com/methodology