# K162594: Craniomaxillofacial Distraction System (CMFD)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: May 8, 2017 after 234 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 K060138 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060138: Synthes (Usa) Craniomaxillofacial Distraction System, Synthes (Usa) (2006) Summary page 4.

## Indications for use
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only. Mandible • The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months • The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger • The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older

Source page: https://510kreport.com/device/K162594
Methodology: https://510kreport.com/methodology