Biorad Medisys Pvt, Ltd.

Biorad Medisys Pvt, Ltd. specializes in orthopedic devices, specifically the Genius/Genuin Total Knee System. This is a prosthetic knee replacement designed for total knee arthroplasty, intended to restore joint function and alignment in patients suffering from degenerative knee conditions. The system includes modular components tailored for surgical precision.

Biorad Medisys Pvt, Ltd. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to U.S. regulatory requirements, including FDA clearance processes.

The Genius/Genuin Total Knee System is listed in the FDA’s 510(k) database, which tracks Class II medical devices that have undergone the 510(k) premarket notification process. This registry confirms the device’s regulatory status under U.S. law, though it does not imply approval—only that the manufacturer has demonstrated substantial equivalence to a legally marketed predicate device.

The Genius/Genuin Total Knee System falls under FDA Class II classification. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The 510(k) clearance process is used to demonstrate that the device meets these regulatory requirements.