Synthes Mandible External Fixator
by Synthes (Usa) 510(k)
Active
510(k) K040169
Overview
The Synthes Mandible External Fixator is a Class II external mandibular fixator and distractor, designed for stabilization of maxillofacial fractures. It provides rigid fixation for severe open mandibular fractures, highly comminuted closed fractures, nonunions, delayed unions (especially infection-related), fractures associated with infections, tumor resections, and facial deformities. The device employs adjustable components such as parallel pin clamps, 4.0/2.5 Schanz screws, 2.0 mm K-wires, and 4.0 mm titanium rods to achieve precise alignment and support.
This device is supplied as a sterile kit and is intended for use in clinical or surgical settings by surgeons. It is compatible with MRI environments and includes multiple registration numbers (e.g., 1032347, 3000270450) under FDA 510(k) clearance (K040169) with a traditional review pathway. Components are reusable or single-use depending on the specific application, and storage follows standard sterile medical device protocols. Regulatory compliance is governed by FDA regulation number 872.4760.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040169 | Date14 Apr 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1009-2015
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.
Specification
- 510(k) Number
- FDA Product Code
- MQN
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synthes (Usa)
Questions
What clinical conditions is the Synthes Mandible External Fixator designed to treat?
This device is specifically engineered for stabilization of maxillofacial fractures, including severe open mandibular fractures, highly comminuted closed fractures, nonunions, delayed unions (especially infection-related), fractures associated with infections, tumor resections, and facial deformities. Its adjustable components—such as parallel pin clamps, Schanz screws, and titanium rods—enable precise alignment and support for complex cases.
How is the Synthes Mandible External Fixator supplied, and what sterility standards apply?
The fixator is supplied as a sterile kit, ensuring readiness for clinical or surgical use. Sterility is maintained according to standard medical device protocols, and the device is compatible with MRI environments, making it suitable for patients requiring imaging during treatment.
Are components of the Synthes Mandible External Fixator reusable or single-use?
Component reuse depends on the specific application. While some parts may be designed for reuse under sterile conditions, others may be intended for single-use to ensure patient safety and infection control. Always follow manufacturer guidelines and facility protocols for proper handling and reprocessing.
What registration numbers or model references identify this device?
The Synthes Mandible External Fixator includes multiple registration numbers under FDA 510(k) clearance (K040169), such as 1032347, 3000270450, and others listed in the OpenFDA database. These identifiers help distinguish specific configurations or variants of the device.
How should the Synthes Mandible External Fixator be stored?
Storage follows standard sterile medical device protocols to preserve integrity and sterility. The kit should be kept in a clean, dry environment, protected from contamination, and stored according to manufacturer instructions to ensure functionality and compliance with regulatory requirements.