De Novo Granted for ‘Smart Knee’ Replacement

FDA has granted de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart knee for total knee replacement surgery. Persona IQ combines Zimmer Biomet’s Persona Personalized Knee, with Canary Medical's proprietary implantable canturio te tibial extension sensor technology that measures and determines range of motion, step count, walking speed and other gait metrics, according to the companies. Persona IQ will work together with Zimmer Biomet's remote care management platform, mymobility with Apple Watch, as well as other components of the ZBEdge Connected Intelligence Suite.

“Once surgically implanted in the knee, Persona IQ records and wirelessly transmits a wide range of gait data to a patient’s personal base station at home,” the companies say. “The data are then securely delivered to a cloud-based platform” where surgeons can then assess post-surgery recovery progress by comparing pre-operative mobility metrics with post-operative gait metrics collected by the device.