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Legal, Clinical & Regulatory

Extremity Medical Gains FDA Clearance for KinematX Total Wrist

The device is specifically designed to negate common risks of radial implants, such as limited range of motion, subluxation, distal component failure and osteolysis.   

COVID-19: What CDRH Wants You to Know about Regulatory Submissions and Clinical Trials

FDA’s Center for Devices and Radiological Health issued a letter to industry regarding what to expect as companies and the agency respond to the COVID-19 pandemic. In general: expect help.   

DePuy Synthes Announces CE Mark for BI-MENTUM Dual Mobility Hip

Currently available in the U.S., BI-MENTUM is slated to enter European markets in April 2020. The system complements other hip stems with highly polished necks, including the company's CORAIL Hip System that has more than 2.5 million implantations to date.