A Combined External Fixator is a modular surgical device used to stabilize and align fractured bones from outside the body. It provides temporary or definitive support for fracture management and joint stabilization during surgery and the healing period.
It is used for management of complex or comminuted fractures, open fractures, limb lengthening, peri-articular fractures, and situations where internal fixation is not feasible or advisable. Indications should be determined by a qualified orthopedic surgeon.
Components are generally manufactured from high-quality medical-grade materials such as stainless steel, titanium alloys, and (for some rod components) carbon fiber. Exact materials vary by model—refer to the product specification sheet for details.
'Class III' indicates the device is designed to meet stringent medical-device safety and performance standards. In some regulatory systems (e.g., FDA), Class III denotes higher-risk devices subject to greater premarket controls. Confirm the device's regulatory approvals and certifications for your region.
This depends on the specific model and manufacturer labeling. Some external fixator systems are reusable after validated cleaning and sterilization; others or certain disposable components may be single-use. Always follow the manufacturer's instructions for use (IFU).
Sterilization methods depend on component materials. Many components are compatible with standard steam autoclave cycles (e.g., 121–134°C). Heat-sensitive parts may require low-temperature sterilization. Always use the sterilization parameters provided in the IFU.
Metallic components will appear on X-ray and fluoroscopy; some systems include radiolucent rods or radiographic markers to aid imaging. Check the product spec for radiolucency and imaging guidance.
Combined external fixators are typically modular, offering a range of pin sizes, rod lengths, clamps, and ring options to accommodate different bones and fracture patterns. Refer to the manufacturer’s catalog for available sizes and configuration kits.
Application requires an experienced orthopedic surgeon trained in external fixation techniques. The procedure includes pin/wire insertion, clamp/rod assembly, and alignment adjustments. Training and familiarity with the specific system are recommended.
Postoperative care typically includes regular wound and pin-site care, monitoring for infection, periodic radiographic assessment of alignment and healing, and mechanical checks of the frame. Specific care protocols should follow institutional standards and surgeon instructions.
Potential complications include pin-site infection, loosening of pins or clamps, neurovascular irritation, malalignment if not properly applied, and soft-tissue problems. Risks are minimized by proper surgical technique, device maintenance, and follow-up.
Inspect for wear, corrosion, damaged threads, and integrity of locking mechanisms. Clean and lubricate as recommended by the manufacturer. Replace any components that show damage or out-of-tolerance wear before reuse.
Some accessories may be interoperable if dimensions and thread types match, but cross-compatibility can vary and may compromise performance. Use manufacturer-approved accessories or verify compatibility before combining components.
Documentation typically includes indications, contraindications, warnings, component lists, assembly and application instructions, sterilization parameters, maintenance guidance, and regulatory certifications. Always review the Instructions for Use (IFU) before use.
Contact the manufacturer or authorized distributor for ordering, available kits, custom configurations, training, and technical support. Provide details on desired components, sizes, and any institutional purchasing requirements.
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