US-based Orthofix Medical announced the 510(k) approval by the US Food and drug administration (FDA) and the first patient case for its TrueLok EVO Ring Fixation system.
The system is claimed to be the first circular fixator in the market designed for complex limb reconstruction and deformity correction procedures that saves time and is easy to use due to its availability as a preassembled frame.
The device features radiolucent rings and struts for better visualisation of bone anatomy both during surgery and post-operative care.
The firm said the system is made from carbon fibre to keep it lightweight and is based on the simple, stable and versatile design of the original TrueLok Ring Fixation system for maximum patient comfort.
Orthofix global orthopaedics president Paul Gonsalves said: “We are constantly evolving our solutions to meet surgeons’ and patients’ needs.
“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.”
The advanced external-fixation system developed received MR conditional clearance, enabling customers to have an MRI with a fixator if required.
The first US case was performed by Dr Amgad Haleem, an associate professor of Orthopedic Surgery at the University of Oklahoma Health Sciences Center in Oklahoma City.
Dr Haleem said: “External ring fixation systems provide an important treatment option for patients in need of deformity correction or complex limb reconstruction.
“Packaged as a sterile preassembled frameset, 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 visualise 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 TrueLok EVO system, adaptable with TrueLok and TL-HEX systems, can be used in the hybrid frame construction with the ProCallus Fixator, XCaliber Fixators and the Galaxy Fixation system.
