Meduloc Receives FDA 510(k) Clearance for Novel Orthopedic Fracture Fixation System

PHILADELPHIA, Nov. 12, 2025 /PRNewswire/ -- Meduloc, an orthopedic surgical device company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprietary intramedullary fracture fixation system. This clearance marks a significant milestone as Meduloc introduces a new category of fixation designed to be able to treat small, long bone fractures.

The Meduloc system offers surgeons a differentiated, approach to fracture fixation, combining a strong, flexible nitinol implant with a deployable prong locking mechanism. The design delivers rotational and length stability while enabling surgeons the choice of avoiding entry through the joint capsule — a technique which may enable earlier mobility, fewer complications, reduced surgical complexity, and allow for faster patient recovery. The platform addresses multiple indications, including metacarpal, radius, ulna, clavicle, and fibula fractures, for both adult and pediatric populations.

"An orthopedic surgeon came to us with a problem, and we developed a solution," said Sarah Sachinis, CEO and President of Meduloc. "We're excited to bring this innovation to market and empower surgeons with technology that improves their ability to treat patients with small bone fractures more effectively."

With clearance secured, Meduloc is preparing for a targeted U.S. commercial launch and expanding its network of surgeon advisors and clinical partners to support adoption and generate real-world evidence.

"This clearance is a key step in our mission to improve fracture care," said Sachinis. "It validates our technology and positions us for rapid growth across multiple applications. With a large, underserved market, Meduloc is well positioned to raise the standard of orthopedic care while driving long-term value for patients, providers, and investors."

For more information about Meduloc and its fracture fixation system, please visit: www.meduloc.com

About Meduloc
Meduloc is a medical device company pioneering innovation in orthopedic surgery with the mission of advancing fracture fixation technology. Meduloc develops solutions designed to improve patient outcomes, simplify surgical procedures, and set new standards in fracture fixation.

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SOURCE Meduloc