# K034045: Oral Osteodistraction Distraction Rod Appliances, Rod 4

- Pathway: 510(k) (Traditional)
- Applicant: Oral Osteodistraction, L.P.
- Decided: Mar 23, 2004 after 85 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 K792561 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972047: KLS-Martin Rigid External Distraction Device, KLS-Martin L.P. (1997) Summary page 1.
- K014001: Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3, Oral Osteodistraction, L.P. (2003) Summary page 1.

## Indications for use
The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

Source page: https://510kreport.com/device/K034045
Methodology: https://510kreport.com/methodology