# K062299: Synthes Sterile Mandible External Fixation Kit

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Aug 31, 2006 after 23 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; 1 cites 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 its predicate without a number.
- (no number) Synthes Mandible External Fixator: named in the summary without a submission number

## Most influential descendants
- K071628: Stryker External Fixation System (2007), 1 descendant of its own
- K072764: KLS Martin Xternal Fixator (2007), 0 descendants of its own

## Indications for use
The 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/K062299
Methodology: https://510kreport.com/methodology