Meduloc has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its intramedullary fracture fixation. The nod means the company has introduced a new category of fixation designed for treating small, long bone fractures.

The Meduloc system combines a strong, flexible nitinol implant with a deployable prong locking mechanism. The design provides rotational and length stability while allowing surgeons the choice of avoiding entry through the joint capsule—this can enable earlier mobility fewer complications, reduced surgical complexity, and quicker patient recovery.

The platform addresses 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, president and CEO 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.”

The company is preparing for a targeted U.S. commercial launch. It’s also growing its network of surgeon advisors and clinical partners to support adoption and gather 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.”