# K960297: Mandibular Bone Distractor II

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Aug 6, 1996 after 197 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 K864403 (1986). 4 ancestors in all.
23 later devices descend from it; 5 cite it directly.
0 of 28 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 2.
- K864403: Monticelli Spinelli External Fixation System, Howmedica Corp. (1986) Summary page 2.
- K914558: Traumafix (TM) External Fixator, Synthes (Usa) (1992) Summary page 2.
- K945500: Wells Johnson Fixation System, Wells Johnson Co. (1995) Summary page 2.
- (no number) Normed Device - distributed in the United States by Ace Surgical Supply Co.: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K792561: Mini-H-Fixation, Geny Medical, Inc. (1979). Our OCR of the scanned summary read K792561, FDA’s number for Mini-H-Fixation (Geny Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hoffman Mini Fixator - Howmedica”. Kept off the family tree. Summary page 2.

## 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
The Mandibular Bone Distractor II is intended to be used in the treatment of conditions such as severe mandibular deficiency, post-surgical mandibular defects, or post-traumatic defects of the mandible. This device is intended to function as a stabilizer and mandibular lengthener. Bone transport procedures may also be performed. This device will allow linear and angular distraction of the mandible. The Mandibular Bone Distractor is intended for use in either adults or children.

Source page: https://510kreport.com/device/K960297
Methodology: https://510kreport.com/methodology