# K010139: Zurich Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jun 29, 2001 after 163 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
No predicates in its family tree.
14 later devices descend from it; 8 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043434: Osteomed Pediatric Intraoral Mandibular Distraction System (2005), 5 descendants of its own
- K062851: Osteomed Pediatric Intraoral Mandibular Distraction System, Extended (2006), 2 descendants of its own
- K170818: Craniomaxillofacial Distraction System (CMFD) (2017), 1 descendant of its own
- K161470: Internal Distraction - Sterile (2016), 1 descendant of its own
- K133398: Stryker Pediatric Mandible Distractor (2014), 1 descendant of its own

Source page: https://510kreport.com/device/K010139
Methodology: https://510kreport.com/methodology