# K072764: KLS Martin Xternal Fixator

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Dec 20, 2007 after 83 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: 2 generations back to K961916 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071628: Stryker External Fixation System, Stryker Cmf (2007) Summary page 1.
- K050378: Synthes Mandible External Fixator, Synthes (Usa) (2005) Summary page 1.
- K901095: BI-Phase Set, Oral, Maxillofacial Surgery, Grimm & Norton (1990) Summary page 1.

## Indications for use
KLS Martin Xternal 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 facialfractures, burn maintenance, and bone grafting defects.

Source page: https://510kreport.com/device/K072764
Methodology: https://510kreport.com/methodology