Zimmer Biomet and Canary Medical announce FDA De Novo Classification Grant for smart knee implant
Zimmer Biomet Holdings, Inc. and Canary Medical, a medical data company, announced U.S. Food and Drug Administration (FDA) De Novo classification grant and authorization to market the tibial extension for Persona IQ, a smart knee cleared by the FDA for total knee replacement surgery.
Persona IQ combines Zimmer Biomet's proven and trusted knee implant, Persona The Personalized Knee, with Canary Medical's proprietary implantable canturio tibial extension sensor technology that measures and determines range of motion, step count, walking speed and other gait metrics. Persona IQ will work together with Zimmer Biomet's remote care management platform, mymobility with Apple Watch, as well as other components of the 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 data are then securely delivered to a cloud-based platform.
Surgeons can assess post-surgery recovery progress by comparing pre-operative mobility metrics captured by mymobility, with post-operative gait metrics collected by Persona IQ. Ultimately, the data from Persona IQ will be seamlessly integrated with pre-, intra- and post-operative data collected by the ZBEdge Connected Intelligence Suite and analyzed by OrthoIntel Orthopedic Intelligence Platform to provide surgeons with objective data as a supplement to patient care.