# K042278: Oral Osteodistraction Rod Appliance (Rod 5)

- Pathway: 510(k) (Traditional)
- Applicant: Oral Osteodistraction, L.P.
- Decided: Jan 28, 2005 after 158 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: 1 generation back to K002152 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002152: Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction, KLS-Martin L.P. (2000) Summary page 1.

## Most influential descendants
- K080458: Mis Crest Widener (2008), 0 descendants of its own

## Indications for use
The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.

Source page: https://510kreport.com/device/K042278
Methodology: https://510kreport.com/methodology