Zimmer Biomet, Canary Medical land FDA de novo clearance for sensor-equipped 'smart' knee implant

Total knee replacement surgery just got a bit of an IQ boost.

The FDA offered up a de novo clearance for Zimmer Biomet and Canary Medical’s Persona IQ system, marking it as the first “smart” knee implant to receive the agency’s OK.

The device builds on Zimmer Biomet’s previously cleared Persona line of patient-specific implants. Designed to be meticulously customized to each patient’s anatomy, the knee system features anatomically accurate implants that can be adjusted in one- or two-millimeter increments to fit into a patient’s original bone structure.

Meanwhile, the Persona IQ gets its intelligence from the former Fierce 15 winner Canary and its gait-tracking sensor technology. The implantable Canturio TE sensor continuously collects gait metrics like range of motion, step count and walking speed, then wirelessly transmits that information to Zimmer Biomet’s cloud-based data-tracking platform.

RELATED: Zimmer Biomet rounds out surgical robot lineup with FDA-cleared Rosa Hip system

By combining their technologies, Zimmer Biomet and Canary have developed a total knee replacement system that not only is hyper-personalized to each patient’s anatomical needs but also offers real-time remote monitoring data to help surgeons and care teams track their patients’ post-op recovery over time—rather than having to rely on self-reported metrics to estimate progress.

Persona IQ will join Zimmer Biomet’s other connected devices on the ZBEdge platform. Care teams can use the platform’s clinical intelligence software to track and identify long-term trends in remote monitoring data like those gathered by the sensors in the Persona IQ system.

The platform also delivers educational modules, exercise tutorials, telehealth visits and more directly to patients through ZBEdge’s MyMobility feature, which connects to iPhones and Apple Watches. In patients implanted with Persona IQ, MyMobility will also be used to collect pre-op gait metrics to serve as a comparison to the sensor-collected post-op data.

“Persona IQ reflects our shared belief that automatic, reliable and accurate data collection and analysis represents the future of orthopedic care,” said William Hunter, M.D., CEO of Canary Medical. “The launch of Persona IQ marks the start of an exciting, ongoing partnership with Zimmer Biomet designed to innovate smart implant technologies that help joint replacement patients regain and maintain their mobility with confidence.”

RELATED: Fierce Medtech’s 2020 Fierce 15 | Canary Medical

The FDA’s clearance of the Persona IQ system comes soon after the agency’s nod for another of Zimmer Biomet’s connected orthopedic surgery technologies. Earlier this month, the company snagged a 510(k) clearance for Rosa Hip, its robotic surgery system for direct anterior hip replacements, which is also hosted on the ZBEdge platform to collect data before, during and after the procedure to assess recovery progress.

Looking ahead, the medtech giant will soon begin rolling out the Persona IQ system while continuing to work with Canary Medical to develop new smart orthopedic implant technologies. The Canadian startup—a 2020 Fierce 15 honoree—was founded with a goal of building Internet of Things-connected devices that send real-time data directly to clinical teams in hopes of improving patient outcomes.