# K040169: Synthes Mandible External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 14, 2004 after 79 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- 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 its predicate without a number.
- (no number) Synthes Mini External Fixator: named in the summary without a submission number

## Most influential descendants
- K143285: Mandible External Fixator - MR Conditional (2015), 0 descendants of its own

## Recalls of this device
- Oct 17, 2014 · Class II · Z-1009-2015: Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/o

## Indications for use
Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Source page: https://510kreport.com/device/K040169
Methodology: https://510kreport.com/methodology