# K013618: Intraoral Mandibular Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Aug 14, 2002 after 282 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). 12 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990944: Osteomed Intraoral Distraction System, Osteomed Corp. (1999) Summary page 1.
- K964649: Vazquez Diner Intraoral Distraction Device, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K972166: Guerrero - Bell Distractor, Howmedica Leibinger, Inc. (1997) Summary page 1.

## 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
- K133398: Stryker Pediatric Mandible Distractor (2014), 1 descendant of its own
- K121502: Synthes Curvilinear Distraction System (2012), 1 descendant of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.

Source page: https://510kreport.com/device/K013618
Methodology: https://510kreport.com/methodology