# K170818: Craniomaxillofacial Distraction System (CMFD)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: Dec 7, 2017 after 262 days
- Product code: PBJ (Cranial Distraction System)
- Device class: 2
- Regulation: 21 CFR 882.5330
- 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 K010139 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010139: Zurich Distraction System, KLS-Martin L.P. (2001) Summary page 4.
- K060138: Synthes (Usa) Craniomaxillofacial Distraction System, Synthes (Usa) (2006) Summary page 4.

## Most influential descendants
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own

## 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 cranium, where gradual bone distraction is required in adults and pediatric patients. Cranium The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.

Source page: https://510kreport.com/device/K170818
Methodology: https://510kreport.com/methodology