MiRus announced it has received U.S. Food and Drug Administration (FDA) 510(k) and commercially launched its IO expandable wedge osteotomy system, a solution designed to bring intraoperative precision and adjustability to foot and ankle osteotomy procedures.

The IO system is powered by the company’s MoRe Superalloy and MoRe Expansion Engine. The system introduces controlled, incremental expandability to Evans osteotomies, which historically relied on static, fixed-size wedges. The implant lets surgeons fine-tune correction in real time to address a limitation in lateral column lengthening and midfoot reconstruction.

Rather than traditional fixed wedges chosen through preoperative planning and intraoperative trials, the IO expandable wedge osteotomy allows gradual expansion after placement. Surgeons are able to access hindfoot alignment, forefoot abduction, and sagittal and transverse plane balance during distraction, then lock the implant once correction is achieved.

The device also accommodates bone graft to stimulate 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, Orthopedic 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 new system builds on the success of MiRus’ expandable platform tech using the MoRe Superalloy, an advanced material designed for high strength, fatigue resistance, and enhanced flexibility.

“We are committed to delivering meaningful innovation that enhances precision, efficiency, and patient outcomes,” said Andy Bishop, VP of sales, Extremities at MiRus. “The IO Expandable Wedge Osteotomy System represents the next step in our strategy to bring adaptable, surgeon-driven solutions to the foot and ankle market.”