# K051946: Modus Modular Distraction Osteogenesis System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis, Inc.
- Decided: Aug 22, 2005 after 35 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K080542: Distrax (2008), 0 descendants of its own

## Indications for use
The Modus® Modular Distraction Osteogenesis System is a subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses including: treatment of hemifacial microsomia, mandibular hypoplasia, microglossia, defects of the alveolar ridge, atrophic bone segments in the mandible and maxilla, mandibular symphysis widening, growth disturbances of the ascending corpus/ascending ramus, and LeFort I, and LeFort II/II advancements.

Source page: https://510kreport.com/device/K051946
Methodology: https://510kreport.com/methodology