# K093299: Synthes Orthodontic Bone Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 16, 2010 after 421 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: 5 generations back to K894844 (1990). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033767: Dual Top Anchor System Screws, Jeil Medical Corporation (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K060473: TTC Plate, New Deal, S.A. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K113650: Orthofix Screw (2012), 1 descendant of its own
- K201919: Blue Sky Bio TAD (2020), 0 descendants of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.

Source page: https://510kreport.com/device/K093299
Methodology: https://510kreport.com/methodology