# K990944: Osteomed Intraoral Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Jun 16, 1999 after 86 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: 4 generations back to K792561 (1979). 11 ancestors in all.
7 later devices descend from it; 1 cites 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)
- 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
- K013618: Intraoral Mandibular Distraction System (2002), 6 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K990944
Methodology: https://510kreport.com/methodology