# K220050: KLS Martin IPS Distraction

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Aug 11, 2022 after 217 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: 5 generations back to K792561 (1979). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161470: Internal Distraction - Sterile, KLS Martin L.P. (2016) Summary page 4.

## Indications for use
KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.

Source page: https://510kreport.com/device/K220050
Methodology: https://510kreport.com/methodology