# K991875: K-L-W Intraoral Distractor

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Aug 18, 1999 after 77 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: 3 generations back to K792561 (1979). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973275: KLS-Martin Intraoral Distractor, KLS-Martin L.P. (1997) Summary page 1.

## Most influential descendants
- K161470: Internal Distraction - Sterile (2016), 1 descendant of its own
- K220050: KLS Martin IPS Distraction (2022), 0 descendants of its own
- K100833: Syle Smartip (2010), 0 descendants of its own

## Indications for use
The indications for use are an uni-directional, intro-oral device for the distraction of facial bones.

Source page: https://510kreport.com/device/K991875
Methodology: https://510kreport.com/methodology