# K040083: Synthes External Midface Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 31, 2004 after 76 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
The Synthes External Midface Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a Lefort II or III osteotomy, and/or the cranium utilizing a monoblioc osteotomy in adult and pediatric populations where gradual bone distraction is required.

Source page: https://510kreport.com/device/K040083
Methodology: https://510kreport.com/methodology