# K972047: KLS-Martin Rigid External Distraction Device

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jun 24, 1997 after 22 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K034045: Oral Osteodistraction Distraction Rod Appliances, Rod 4 (2004), 0 descendants of its own

## Indications for use
The KLS-Martin Rigid External Distraction (RED) device is utilized for the purpose of maxillary and midface osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies.

Source page: https://510kreport.com/device/K972047
Methodology: https://510kreport.com/methodology