MALVERN, PA / ACCESS Newswire / November 12, 2025 / Pace Surgical, a Runway Healthcare portfolio company pioneering advancements in lower extremity fixation, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Ultra Compression Screw System, indicated for the internal fixation and stabilization of arthrodesis, osteotomies, fractures, and nonunion of the foot and ankle.
The Ultra Compression Screw System introduces a patent-pending approach to mechanical compression and fixation, addressing longstanding challenges in achieving consistent bone apposition and stable union across a variety of anatomic sites. Its design delivers predictable compression, high pull-out strength, and consistent torque upon insertion as a new standard for forefoot, midfoot, and hindfoot applications.
"Surgeons know that reliable compression and ease of use determine success in foot and ankle reconstruction," said Bill Rhoda, Chief Technology Officer of Pace Surgical and General Partner of Runway Healthcare. "The Ultra Compression Screw System was engineered in direct collaboration with surgeons to provide reproducible results and tactile feedback, and to restore anatomical constructs with purpose-built solutions. This clearance accelerates our plans to bring a differentiated solution to a growing procedural market."
James C. Kreig, M.D., Chief of Orthopaedic Trauma and Fracture Care of Rothman Orthopeadics' and Professor of Orthopaedic Surgery at Thomas Jefferson University in Philadelphia, and head of Pace Surgical Surgeon Design Team, stated, "As a surgeon, I know that much of how well a screw functions has to do with how accurately it has been inserted. In that regard, the handling characteristics are essential. How accurately can I place it, and can any surgeon do it as well? The 'secret sauce' of the Ultra Screw is a unique set of features that make it easier to start and provide for a more consistent torque required to insert. The predictable 'just right' insertional torque makes it easier to fully tighten the screw, without causing it to strip. I look forward to using the Ultra Screw in my practice."
Pace's Surgeon Design Team consists of some of the top minds in orthopedic reconstruction and foot and ankle surgery, globally from Trauma, Orthopedics, and Podiatry, with Jim Krieg, MD, Samir Mehta, MD, Lew Schon, MD, Greg Guyton, MD, Nicholas Romansky, DPM, and Steven Soondar, DPM.
With more than 1.5 million trauma and reconstruction foot and ankle procedures performed annually in the U.S., the market for stable, easy-to-use fixation systems continues to expand as patient demand and surgeon efficiency pressures increase. Pace Surgical's Ultra Compression Screw System delivers a combination of performance, simplicity, and versatility that appeals to both high-volume reconstructive surgeons and strategically positioned acquirers seeking a next-generation foot and ankle platform.
The Ultra Compression Screw System features a self-starting tip geometry and thread form that or optimizes bone engagement, and reduced stripping, and allows for consistent torque through varying bone quality and densities.
The company plans a limited release of the Ultra Compression Screw System in select surgical centers, followed by a broader commercial rollout later in 2026 of Pace's full reconstruction offering, to include anatomical locking plates and screws.
Pace Surgical operates within Runway Healthcare, a MedTech venture studio that develops and scales breakthrough technologies in Orthopedics, Trauma, and Spine through a focused, capital-efficient model.
For more information, visit https://pace-surgical.com.
Forward-Looking Statements:
This press release contains "forward-looking statements" concerning the development of Pace Surgical 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. Pace Surgical undertakes no obligation to update any forward-looking statements for any reason.
About Pace Surgical:
Pace Surgical was founded to provide foot and ankle surgeons with anatomically appropriate surgical solutions to preserve anatomical constructs and quality of life for patients. Pace Surgical's majority stockholder is Runway Healthcare, LP, a MedTech accelerator investment fund. Visit Pace-Surgical.com.
About Runway Healthcare:
Runway Healthcare is an early-stage medical device Venture Studio focused on early-stage technology in the Orthopedic, Cardiovascular, and Neurology sectors. Runway Healthcare 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 company's ownership to larger multi-national healthcare companies for commercialization. Visit https://runwayhc.com.
Contact Information
Jeffrey O'Donnell, Jr.
Chief Executive Officer
info@runwayhc.com
SOURCE: Pace Surgical
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/pace-surgical-receives-fda-510k-clearance-for-ultra-compression-screw-1100540