MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System

ATLANTA, Feb. 23, 2026 /PRNewswire/ -- MiRus® today 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 bone graft to promote biological integration and osteotomy healing.

“The IO™ Expandable Wedge Osteotomy introduces a level of intraopera

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