USFDA15 Jan 2025, 11:32 pm
Shalby Advanced Technologies Receives US FDA Approval for DuraniomTM Knee Replacement Device
AI Summary
Shalby Advanced Technologies (SAT) Inc., USA, a subsidiary of Shalby Ltd, has received U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Clearance for DuraniomTM, its Primary Total Knee Replacement device with TiNbN coating. The approval was granted on January 14, 2025, based on the safety and effectiveness data, which determined the device to be substantially equivalent to legally marketed predicate devices.
Key Highlights
- Shalby Advanced Technologies (SAT) Inc., USA received US FDA approval for its Primary Total Knee Replacement device DuraniomTM
- The approval was granted based on safety and effectiveness data
- DuraniomTM features a TiNbN coating
- FDA determined the device to be substantially equivalent to legally marketed predicate devices
- The approval was granted on January 14, 2025