Press release
Orthofix Announces FDA Clearance and First Patient Cases With the TrueLok EVO Ring Fixation System
Designed for complex limb reconstruction and deformity correction procedures, the system features radiolucent rings and struts for clearer visualization
About this update from Orthofix Medical Inc.
[{"type":"text","content":"\nDesigned for complex limb reconstruction and deformity correction procedures, the system features radiolucent rings and struts for clearer visualization under X-ray\n\n LEWISVILLE, Texas--(BUSINESS WIRE)--\nOrthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the U.S. Food and Drug Administration 510(k) clearance and the first patient cases with the TrueLok™ EVO Ring Fixation System. Designed for complex limb reconstruction and deformity correction procedures, the TrueLok EVO system is the only circular fixator on the market that features both radiolucent rings and struts to enable clear radiographic visualization. This innovative design allows physicians to better assess bone anatomy both during surgery and post-operative care. The TrueLok EVO system is also the first circular external fixation kit available as a preassembled frame in ready-to-use single use sterile packaging, allowing for ease of application and potential time-saving during surgery, particularly when treating post-traumatic injuries.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220316005167/en/The TrueLok EVO system is the only circular fixator on the market that features both radiolucent rings and struts to enable clear radiographic visualization. (Photo: Business Wire)\n“We are constantly evolving our solutions to meet surgeons’ and patients’ needs,” said Orthofix President of Global Orthopedics Paul Gonsalves. “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.”\n\nThe TrueLok EVO system is an advanced external-fixation system made of carbon fiber, making the device lightweight for improved patient comfort while maintaining the same simple, stable and versatile benefits of the original TrueLok Ring Fixation system. The TrueLok EVO system has MR conditional clearance, enabling patients, in specific conditions, to have an MRI with the fixator applied if needed.\n\n“External ring fixation systems provide an important treatment option for patients in...