# K962272: Synthes Mandible Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 30, 1996 after 78 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 K792561 (1979). 1 ancestor in all.
27 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792561: Mini-H-Fixation, Geny Medical, Inc. (1979) Summary page 1.

## Most influential descendants
- K964649: Vazquez Diner Intraoral Distraction Device (1997), 17 descendants of its own
- K972166: Guerrero - Bell Distractor (1997), 11 descendants of its own
- K973275: KLS-Martin Intraoral Distractor (1997), 8 descendants of its own
- K972154: Cohen Distractor (1997), 8 descendants of its own
- K990944: Osteomed Intraoral Distraction System (1999), 7 descendants of its own

## Indications for use
The Synthes Mandible Distractor 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/K962272
Methodology: https://510kreport.com/methodology