# K121502: Synthes Curvilinear Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes, Inc.
- Decided: Aug 23, 2012 after 94 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: 7 generations back to K792561 (1979). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080153: Synthes (Usa) Curvilinear Distraction System, Synthes (Usa) (2008) Summary page 1.
- K060138: Synthes (Usa) Craniomaxillofacial Distraction System, Synthes (Usa) (2006) Summary page 1.
- K013618: Intraoral Mandibular Distraction System, Osteomed Corp. (2002) Summary page 3.
- K043434: Osteomed Pediatric Intraoral Mandibular Distraction System, Osteomed LP (2005) Summary page 1.

## Most influential descendants
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
The Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger. The Synthes Curvilinear Distraction System is intended for single use only.

Source page: https://510kreport.com/device/K121502
Methodology: https://510kreport.com/methodology