# K043434: Osteomed Pediatric Intraoral Mandibular Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Feb 10, 2005 after 59 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: 6 generations back to K792561 (1979). 14 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010139: Zurich Distraction System, KLS-Martin L.P. (2001) Summary page 1.
- K013618: Intraoral Mandibular Distraction System, Osteomed Corp. (2002) Summary page 1.
- (no number) KLS-Martin Micro Mandibular Distractor: named in the summary without a submission number

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

## Indications for use
Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.

Source page: https://510kreport.com/device/K043434
Methodology: https://510kreport.com/methodology