
Shalby Limited is proud to announce that Shalby Advanced Technologies (SAT) Inc., its step-down subsidiary based in the USA, has received U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Clearance for its innovative product, Duraniom™.
Duraniom™, a primary total knee replacement device, features an advanced TiNbN coating designed to enhance durability and patient outcomes. The FDA clearance, granted on January 14, 2025, confirms the device’s safety and effectiveness, deeming it substantially equivalent to legally marketed predicate devices.
This milestone reinforces Shalby’s commitment to innovation in orthopedic implants and strengthens its position in the global medical device industry.
Shalby Limited, headquartered in Ahmedabad, India, is a leading player in the healthcare sector, specializing in multi-specialty hospitals, joint replacement surgeries, and advanced medical technologies. With a growing global footprint, the company is dedicated to improving lives through innovation and excellence in healthcare.