# K014001: Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3

- Pathway: 510(k) (Traditional)
- Applicant: Oral Osteodistraction, L.P.
- Decided: Feb 4, 2003 after 427 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: 3 generations back to K792561 (1979). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973275: KLS-Martin Intraoral Distractor, KLS-Martin L.P. (1997) Summary page 1.
- K962272: Synthes Mandible Distractor, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K034045: Oral Osteodistraction Distraction Rod Appliances, Rod 4 (2004), 0 descendants of its own

## Indications for use
The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

Source page: https://510kreport.com/device/K014001
Methodology: https://510kreport.com/methodology