# K964649: Vazquez Diner Intraoral Distraction Device

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: Jan 24, 1997 after 65 days
- Product code: JEY (Plate, Bone)
- 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: 2 generations back to K792561 (1979). 5 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945674: Mandibular Bone Distractor, Howmedica Corp. (1995) Summary page 1.
- K945500: Wells Johnson Fixation System, Wells Johnson Co. (1995) Summary page 1.
- K914558: Traumafix (TM) External Fixator, Synthes (Usa) (1992) Summary page 1.
- K962272: Synthes Mandible Distractor, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- 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
- K013618: Intraoral Mandibular Distraction System (2002), 6 descendants of its own
- K043434: Osteomed Pediatric Intraoral Mandibular Distraction System (2005), 5 descendants of its own

## Indications for use
It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

Source page: https://510kreport.com/device/K964649
Methodology: https://510kreport.com/methodology