# K060138: Synthes (Usa) Craniomaxillofacial Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 2, 2006 after 134 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 5 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KLS Martin - Zurich Distraction System: named in the summary without a submission number
- (no number) KLS Martin - Micro Zurich Distractor: named in the summary without a submission number

## Most influential descendants
- K170818: Craniomaxillofacial Distraction System (CMFD) (2017), 1 descendant of its own
- K121502: Synthes Curvilinear Distraction System (2012), 1 descendant of its own
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own
- K162594: Craniomaxillofacial Distraction System (CMFD) (2017), 0 descendants of its own

## Recalls of this device
- Apr 16, 2014 · Class I · Z-2148-2014: DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.
- Jun 12, 2013 · Class II · Z-1726-2013: The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported withi

## Indications for use
The Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The Synthes CMF Distraction System is intended for single use only. The Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The Synthes Pediatric CMF Distraction System is intended for single use only.

Source page: https://510kreport.com/device/K060138
Methodology: https://510kreport.com/methodology