MiRus announced FDA 510(k) clearance and commercial launch of the IO Expandable Wedge Osteotomy System, an innovative solution designed to bring intraoperative precision and adjustability to foot and ankle osteotomy procedures.
Powered by MiRus' proprietary MoRe Superalloy and the MoRe Expansion Engine, the IO Expandable Wedge Osteotomy system introduces controlled, incremental expandability to Evans osteotomies, a procedure that has historically relied on static, fixed-size wedges. The implant enables surgeons to fine-tune correction in real time, addressing a longstanding limitation in lateral column lengthening and midfoot reconstruction.
Unlike traditional fixed wedges selected through preoperative templating and intraoperative trials, the IO Expandable Wedge Osteotomy allows gradual expansion after placement. Surgeons can assess hindfoot alignment, forefoot abduction, and sagittal and transverse plane balance during distraction, then lock the implant once optimal correction is achieved. The device also accommodates a bone graft to promote biological integration and osteotomy healing.
"The IO Expandable Wedge Osteotomy introduces a level of intraoperative precision we have not previously had in lateral column lengthening," said Selene G. Parekh, MD, MBA, Orthopaedic Foot & Ankle Surgeon, Rothman Orthopaedics and Professor of Orthopaedic Surgery, Thomas Jefferson University. "The ability to gradually expand the implant allows controlled correction while directly evaluating alignment. Once the desired position is achieved, it can be secured with structural stability."
The IO Expandable Wedge Osteotomy system builds on the clinical success of MiRus' expandable platform technologies, utilising the MoRe Superalloy - an advanced material engineered for high strength, fatigue resistance, and enhanced flexibility. These properties enable new design approaches in segments that have historically seen limited innovation.
"The appropriate sizes for the Evans wedge have recently been further defined in the orthopaedic literature," commented Jesse Doty, MD, Integrity Orthopedics and Sports Medicine, Chattanooga, TN. "MiRus has leveraged their MoRe Superalloy to create an adjustable implant that allows surgeons to tailor the amount of correction. This transforms the Evans osteotomy from a static procedure into a dynamic construct."
