# K973275: KLS-Martin Intraoral Distractor

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Nov 20, 1997 after 79 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 K792561 (1979). 2 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962272: Synthes Mandible Distractor, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K991875: K-L-W Intraoral Distractor (1999), 3 descendants of its own
- K983515: KLS Intraoral Vertical Distractor (1998), 3 descendants of its own
- K161470: Internal Distraction - Sterile (2016), 1 descendant of its own
- K014001: Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3 (2003), 1 descendant of its own
- K220050: KLS Martin IPS Distraction (2022), 0 descendants of its own

## Indications for use
The KLS-Martin Intraoral Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. (Micrognathia, Hemifacial Microsomia, Congenital Craniofacial Syndromes)

Source page: https://510kreport.com/device/K973275
Methodology: https://510kreport.com/methodology