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 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 utilizing 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 Evans wedge has recently been further defined in the orthopedic 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."

"We are committed to delivering meaningful innovation that enhances precision, efficiency, and patient outcomes," said Andy Bishop, Vice President 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."

"For surgeons treating adult-acquired flatfoot and complex multiplanar deformities, enhanced intraoperative control may improve reproducibility, alignment accuracy, and long-term structural outcomes," summarized Dr. Parekh.

MiRus continues to expand its extremities portfolio, building on its ultra-thin plating systems for midfoot and ankle fractures with a broader range of trauma fixation, ankle fusion plating, and expandable solutions to meet increasing clinical demand.

About MiRus, LLC.
MiRus is a life sciences company headquartered in Atlanta, Georgia that has developed and is commercializing proprietary novel biomaterials and implants that are transforming medicine by making surgeries less invasive and implants safer and more durable. www.mirusmed.com. 

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

* MiRus®, MoRe®, IO™ are all trademarks of MiRus, LLC. 

Contact:
Mahesh Krishnan
Chief Commercial Officer
[email protected]
770-317-5564

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SOURCE MiRus