By: IPP Bureau
Last updated : November 19, 2025 11:09 am
The cleared system pairs a flexible nitinol implant with a deployable prong-locking mechanism, delivering rotational and length stability
Leading medical device company Meduloc has secured and FDA clearance for its proprietary intramedullary fracture-fixation system — a move that creates an entirely new category of devices for stabilizing small, long-bone fractures.
The cleared system pairs a flexible nitinol implant with a deployable prong-locking mechanism, delivering rotational and length stability while giving surgeons the option to avoid entering the joint capsule. The approach is designed to reduce complications, shorten procedures, and speed recovery. Indications span metacarpal, radius, ulna, clavicle, and fibula fractures in both adults and children.
“An orthopedic surgeon came to us with a problem, and we developed a solution,” said Sarah Sachinis, Meduloc’s CEO and president. “This innovation gives surgeons a more effective way to treat small-bone fractures.”
With the regulatory milestone -- 510(k) --complete, Meduloc is preparing for a targeted U.S. commercial launch and expanding its network of surgeon advisors and clinical partners to build adoption and real-world evidence.
“This clearance is a key step in our mission to improve fracture care,” Sachinis said. “It validates our technology and positions us for rapid growth in a large, underserved market.”
Meduloc develops orthopedic surgical technologies aimed at improving outcomes, simplifying procedures, and raising the standard of fracture fixation.