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The TrueLok™ EVO System is a modular circular external fixation system based on Ilizarov principles. TL-EVO consists of external supports (rings and footplates), variable length struts and a variety of connection elements that build the external frame.
DO NOT USE the TL-EVO if a surgical candidate exhibits or is predisposed to any of the following contraindications:
– Mental or physiological conditions who are unwilling or incapable of following postoperative care instructions as it could result in a treatment failure in the intended population.
The TL-EVO is intended to provide bone fixation.
The TL- EVO is indicated for fractures, pseudarthrosis / non-unions, lengthening, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g., bone transport) in long bones and in the foot.
TrueLok EVO is designed as an external circular fixator that can also be used for definitive treatment of long bone fractures.
TrueLok EVO larger components (rings and struts) are mainly made of carbon fiber and polymeric materials that make the fixator lightweight and improve patient’s comfort.
The integration of the dynamization module inside the radiolucent struts allows the frame to be dynamized during the post-operative period, without any additional frame revisions by the surgeon.
TrueLok EVO can be used for both temporary and definitive stabilization. The sterile sets give the surgeon the comfort of having all the necessary components, ready to use, with a streamlined configuration. Sterile components guarantee the surgeon the reliability of a brand new system and the safety of a proper sterilized implant. The sterile sets have pre-assembled frames, facilitating the application of the fixator and potentially speeding-up the surgery time.
Rings and struts are made of carbon fiber to enhance the radiolucency of the frame, allowing for a clear visualization of the bone under X-rays.
The initial hand-tightening mechanism on the radiolucent struts allows the surgeon to manipulate the frame without requiring an instrument while performing reduction maneuvers and X-ray intra-operative controls. Using the radiolucent struts with integrated dynamization, the surgeon can decide whether to keep the frame completely locked or to allow the dynamization of the fracture site without changing or replacing any component of the frame.
TrueLok EVO System is MRI conditional, allowing the patient to enter a MRI environment with the fixator applied, if further investigations are needed. (See IFU for the specific conditions that have to be respected.)
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Disclaimer
This information is intended for health care professionals only. Proper surgical procedure is the responsibility of the physician.
Each surgeon must evaluate the appropriateness of a technique based on his or her personal medical credentials and experience, knowing the information reported in the product-specific IFUs. Please note that certain products may not be available in all countries.
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