Shalby receives USFDA clearance for knee replacement device
Shalby Advanced Technologies Inc., USA, a step down subsidiary of the Company has received U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Clearance for DuraniomTM, our Primary Total Knee Replacement device with TiNbN coating, on January 14, 2025.
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Based on the safety and effectiveness data, FDA has determined the device is substantially equivalent to legally marketed predicate devices.
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Located in northern California, Shalby Advanced Technologies, Inc. (SAT), was incorporated in March 2021. In May 2021, SAT purchased the orthopedic implant and instrument technology, including the brand name, from Consensus Orthopedics, a company with almost 30 years’ experience in the orthopedics business. SAT is a manufacturing facility with the distinct advantage of end-to-end integration which includes R&D workrooms, machining, finishing, polishing, cleaning, quality control, sterilization, and packaging solutions. SAT is a global orthopedic company focused on Restoring Mobility and Improving Lives across the world.
