Sam Brusco, Associate Editor03.16.22
Orthofix has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its TrueLok EVO ring fixation system. The first patient cases were also completed using the new system.
TrueLok EVO is designed for complex limb reconstruction and deformity correction procedures. The circular fixator features radiolucent rings and struts for clear radiographic visualization so bone anatomy can be better assessed during surgery and post-op care.
The system is available as a preassembled frame in single-use sterile packaging for ease of application and time-saving, especially when treating post-traumatic injuries.
“We are constantly evolving our solutions to meet surgeons’ and patients’ needs,” Orthofix president of Global Orthopedics Paul Gonsalves told the press. “Orthofix ring fixation systems are the preferred solutions to thousands of surgeons worldwide and have been used to treat more than 80,000 patients to date. Today we are proud to launch the TrueLok EVO system as part of our portfolio of solutions to help healthcare professionals restore patient anatomy, mobility and quality of life.”
TrueLok EVO is made of carbon fiber, making it lightweight. It also has MR conditional clearance so patients in specific conditions can have an MRI with the fixator on if needed.
“External ring fixation systems provide an important treatment option for patients in need of deformity correction or complex limb reconstruction,” said Dr. Amgad Haleem, Associate Professor of Orthopedic Surgery at the University of Oklahoma Health Sciences Center in Oklahoma City, who performed the first U.S. cases. “Packaged as a sterile preassembled frame set, the TrueLok EVO frame presents a streamlined configuration that helps reduce the time needed to prepare the device for the procedure. Additionally, the radiolucent rings and struts make it easier to visualize under X-ray the precise placement of the device on the bone during surgery. Together, these advancements enable us to better treat adults and children across a wide range of bone deformity and trauma conditions.”
The system is intended for fixation of open and closed fractures, limb lengthening by metaphyseal or epiphyseal distractions, treatment of nonunion or pseudarthrosis of long bones and correction of bony or soft tissue defects or deformities in adults and children. It can be used in a hybrid frame configuration with the ProCallus fixator, XCaliber fixators, and the Galaxy Fixation system. It is also compatible with the TrueLok and TL-HEX systems.
Orthofix is at booth #2044 at next week’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting.
TrueLok EVO is designed for complex limb reconstruction and deformity correction procedures. The circular fixator features radiolucent rings and struts for clear radiographic visualization so bone anatomy can be better assessed during surgery and post-op care.
The system is available as a preassembled frame in single-use sterile packaging for ease of application and time-saving, especially when treating post-traumatic injuries.
“We are constantly evolving our solutions to meet surgeons’ and patients’ needs,” Orthofix president of Global Orthopedics Paul Gonsalves told the press. “Orthofix ring fixation systems are the preferred solutions to thousands of surgeons worldwide and have been used to treat more than 80,000 patients to date. Today we are proud to launch the TrueLok EVO system as part of our portfolio of solutions to help healthcare professionals restore patient anatomy, mobility and quality of life.”
TrueLok EVO is made of carbon fiber, making it lightweight. It also has MR conditional clearance so patients in specific conditions can have an MRI with the fixator on if needed.
“External ring fixation systems provide an important treatment option for patients in need of deformity correction or complex limb reconstruction,” said Dr. Amgad Haleem, Associate Professor of Orthopedic Surgery at the University of Oklahoma Health Sciences Center in Oklahoma City, who performed the first U.S. cases. “Packaged as a sterile preassembled frame set, the TrueLok EVO frame presents a streamlined configuration that helps reduce the time needed to prepare the device for the procedure. Additionally, the radiolucent rings and struts make it easier to visualize under X-ray the precise placement of the device on the bone during surgery. Together, these advancements enable us to better treat adults and children across a wide range of bone deformity and trauma conditions.”
The system is intended for fixation of open and closed fractures, limb lengthening by metaphyseal or epiphyseal distractions, treatment of nonunion or pseudarthrosis of long bones and correction of bony or soft tissue defects or deformities in adults and children. It can be used in a hybrid frame configuration with the ProCallus fixator, XCaliber fixators, and the Galaxy Fixation system. It is also compatible with the TrueLok and TL-HEX systems.
Orthofix is at booth #2044 at next week’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting.