FDA Clears Toetal Solution’s Ziptoe Hammertoe System
Company Positioned for Strategic Transaction
MALVERN, PA / ACCESS Newswire / January 8, 2026 / Toetal Solution, Inc., a Runway Healthcare company, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Ziptoe™ Hammertoe System, an implant designed for proximal interphalangeal joint (PIPJ) arthrodesis in hammertoe correction procedures.
The Ziptoe Hammertoe System was developed to deliver consistent fixation while supporting efficient, repeatable surgical workflow. Designed in collaboration with leading foot and ankle surgeons, the system addresses common challenges in hammertoe correction, including implant handling, alignment, and procedural simplicity by incorporating a pre-loaded titanium and nitinol intramedullary implant into a fully disposable surgical kit.
Hammertoe correction represents a meaningful segment within the broader foot and ankle devices market. Industry analysts estimate the global foot and ankle devices market to exceed $5 billion annually, with expectations to surpass $10 billion over the next decade, driven by aging demographics, rising procedure volumes, and continued adoption of implant-based solutions. Within this landscape, the hammertoe segment alone is estimated to generate approximately $350-400 million in annual global revenue, with steady mid-single-digit growth projected through the end of the decade, according to published market research from firms including Grand View Research and Global Market Insights.
“Ziptoe was designed from day one to be a simple, repeatable, and effective solution to an indication that affects so many patients,” said Jeffrey F. O’Donnell, Jr., CEO of Toetal Solution, Inc. “Achieving FDA clearance is a huge accomplishment for our team, and we are thankful to Drs. Stephen Soondar and Nicholas Romansky for their guidance throughout the design process. We are well-positioned with a regulatorily de-risked, strategically ready asset for the right partner that is looking to compete and win.”
Toetal Solution was formed within Runway Healthcare’s venture studio model and, with FDA clearance secured, is being positioned for a strategic transaction. Runway Healthcare intends to evaluate acquisition and partnership opportunities for the company as part of its fund strategy.
Toetal Solution expects limited commercial engagement to support strategic diligence and clinical familiarity while transaction discussions progress.
About Toetal Solutions, Inc.:
Toetal Solutions was founded in 2021 to create easy-to-use and clinically effective solutions for foot and ankle deformities. The Ziptoe Hammertoe System features a sterile packed procedure kit and implant to address ridged hammertoe deformity.
About Runway Healthcare, LP:
Runway Healthcare is an early-stage medical device venture studio focused on early-stage technology in the Orthopedic, Cardiovascular, and Neurology sectors. Runway finances and manages the product development process of its portfolio companies. Upon navigating a portfolio company through the regulatory process, Runway Healthcare will seek to transition the portfolio company’s ownership to a larger multi-national healthcare company for commercialization.
Forward-Looking Statements:
This press release contains “forward-looking statements” concerning the development of Toetal Solutions products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions, and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Toetal Solutions undertakes no obligation to update any forward-looking statements for any reason.
Inquiries: Info@RunwayHC.com
SOURCE: Toetal Solution, Inc
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