# K972166: Guerrero - Bell Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: Aug 11, 1997 after 63 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: 3 generations back to K792561 (1979). 10 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964649: Vazquez Diner Intraoral Distraction Device, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K960297: Mandibular Bone Distractor II, Howmedica Corp. (1996) Summary page 1.
- K950595: Luhr Mandibular/Small Fixation Implants, Howmedica Corp. (1995) Summary page 1.
- K953806: Synthes (Usa) Midfacial System, Synthes (Usa) (1996) Summary page 1.
- (no number) Normed Distractor: named in the summary without a submission number

## Most influential descendants
- 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
- K062851: Osteomed Pediatric Intraoral Mandibular Distraction System, Extended (2006), 2 descendants of its own
- K133398: Stryker Pediatric Mandible Distractor (2014), 1 descendant of its own

## Indications for use
This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device is intended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones.

Source page: https://510kreport.com/device/K972166
Methodology: https://510kreport.com/methodology