# K133398: Stryker Pediatric Mandible Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Mar 20, 2014 after 134 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: 8 generations back to K792561 (1979). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062851: Osteomed Pediatric Intraoral Mandibular Distraction System, Extended, Osteomed LP (2006) Summary page 1.
- K010139: Zurich Distraction System, KLS-Martin L.P. (2001) Summary page 1.
- K092743: The Leibinger Advance Internal Midface Distraction System, Stryker Craniomaxillofacial (2010) Summary page 1.

## Most influential descendants
- K181504: Stryker Pediatric Mandibular Distractor 2 (2018), 0 descendants of its own

## Indications for use
The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor 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/K133398
Methodology: https://510kreport.com/methodology