# K031708: Osteomed Maxillary/Lefort Iii Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Nov 3, 2003 after 154 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972154: Cohen Distractor, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K982604: Lorenz Maxilla (LE Fort) Distraction System, Walter Lorenz Surgical, Inc. (1998) Summary page 1.

## Indications for use
Intended for use in the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OsteoMed Maxillary / LeFort III Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones. The OsteoMed Maxillary / LeFort III Distraction System is intended for single patient use only.

Source page: https://510kreport.com/device/K031708
Methodology: https://510kreport.com/methodology