# K181504: Stryker Pediatric Mandibular Distractor 2

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Sep 11, 2018 after 96 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: 9 generations back to K792561 (1979). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133398: Stryker Pediatric Mandible Distractor, Stryker (2014) Summary page 5.

## Indications for use
The Stryker Pediatric Mandibular Distractor 2 is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandibular Distractor 2 is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.

Source page: https://510kreport.com/device/K181504
Methodology: https://510kreport.com/methodology