# K063792: Osteomed External Mandibular Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Mar 2, 2007 after 70 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 K864403 (1986). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034027: KLS Martin 3DX External Distraction System, KLS-Martin L.P. (2004) Summary page 1.
- K994154: Mod Line of Molina Distractors, 51-600 Series, KLS-Martin L.P. (2000) Summary page 1.
- K981362: Synthes (Usa) External Multi Vector Mandible Distractor, Synthes (Usa) (1998) Summary page 1.
- K992873: Lorenz External Mandibular Distractor, Walter Lorenz Surgical, Inc. (1999) Summary page 1.

## Most influential descendants
- K123885: Osteomed Smartflex Cranial Spring Distractor (2013), 1 descendant of its own
- K230211: CranioXpand (2023), 0 descendants of its own

## Indications for use
The OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction. The OsteoMed External Mandibular Distraction System is intended for use in either adults or pediatric patients. The OsteoMed External Mandibular Distraction System is intended for single patient use only.

Source page: https://510kreport.com/device/K063792
Methodology: https://510kreport.com/methodology