# K080542: Distrax

- Pathway: 510(k) (Traditional)
- Applicant: John W. King
- Decided: Dec 15, 2008 after 292 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051946 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051946: Modus Modular Distraction Osteogenesis System, Medartis, Inc. (2005) Summary page 1.

## Indications for use
The Distrax is intended for mandibular symphyseal widening and mandibular lengthening by distraction osteogenesis. Following the distraction osteogenesis, the Distrax may also be used for temporary stabilization during the consolidation' phase. The Distrax is intended for single patient use only.

Source page: https://510kreport.com/device/K080542
Methodology: https://510kreport.com/methodology