# K945674: Mandibular Bone Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jun 2, 1995 after 196 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
No predicates in its family tree.
25 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960297: Mandibular Bone Distractor II (1996), 23 descendants of its own
- K964649: Vazquez Diner Intraoral Distraction Device (1997), 17 descendants of its own
- K972166: Guerrero - Bell Distractor (1997), 11 descendants of its own
- K972154: Cohen Distractor (1997), 8 descendants of its own
- K990944: Osteomed Intraoral Distraction System (1999), 7 descendants of its own

Source page: https://510kreport.com/device/K945674
Methodology: https://510kreport.com/methodology