# K062851: Osteomed Pediatric Intraoral Mandibular Distraction System, Extended

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Nov 17, 2006 after 53 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: 7 generations back to K792561 (1979). 16 ancestors in all.
2 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)
- K043434: Osteomed Pediatric Intraoral Mandibular Distraction System, Osteomed LP (2005) Summary page 1.
- K994154: Mod Line of Molina Distractors, 51-600 Series, KLS-Martin L.P. (2000) Summary page 1.

## Most influential descendants
- K133398: Stryker Pediatric Mandible Distractor (2014), 1 descendant 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, Extended is intended for single patient use only.

Source page: https://510kreport.com/device/K062851
Methodology: https://510kreport.com/methodology