# K080153: Synthes (Usa) Curvilinear Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 14, 2008 after 112 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have 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) Synthes Craniomaxillofacial (CMF) Distraction System: named in the summary without a submission number
- (no number) Osteomed Intraoral Mandibular Distraction System: named in the summary without a submission number
- (no number) Synthes Multi-Vector Distractor: named in the summary without a submission number

## Most influential descendants
- K121502: Synthes Curvilinear Distraction System (2012), 1 descendant of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
The Synthes (USA) Curvilinear 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. This system is intended for use in either adults or pediatric patients over 1 year old. The Synthes (USA) Curvilinear Distraction System is intended for single use only.

Source page: https://510kreport.com/device/K080153
Methodology: https://510kreport.com/methodology