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K Number
K060138
Device Name
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
Manufacturer
SYNTHES (USA)
Date Cleared
2006-06-02

(134 days)

Product Code
MQN
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

The Synthes Craniomaxillofacial Distraction System, which includes the Pediatric CMF Distraction System, is a modular family of internal distraction osteogenesis devices that are used to gradually lengthen the mandible body and ramus. Each device, when assembled, is comprised of a distractor body, two footplates, and a machine screw to secure the assembly. The system also includes optional activation arms, which can be attached to the activation end of the device to move the point of activation to an area accessible by the activation instrument.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, adjudication methods, or results of comparative effectiveness or standalone studies for the "Synthes Craniomaxillofacial Distraction System". This document is a 510(k) summary indicating substantial equivalence to predicate devices, focusing on regulatory approval rather than detailed performance study results.

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.