Restore Robotics Wins FDA Nod to Remanufacture Da Vinci Xi Instruments

Restore Robotics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for remanufacturing Intuitive Surgical Da Vinci Xi monopolar scissors through its subsidiary Iconocare Health.

The Panama City Beach, Fla.-based company—with a remanufacturing facility in Henderson, Nev.—plans to offer hospitals and surgery centers a cost-effective, sustainable alternative to buying instruments from the original manufacturer. Through its marketing and distribution partnership with Encore Medical Device Repair, the company can deliver remanufactured instruments to U.S. surgical centers and hospitals.

The company believes that hospitals can save significant funds per year by participating in the Restore Robotics and Encore remanufacturing program and free up budget resources for other crucial needs.

“Restore Robotics is deeply committed to helping hospitals reduce the cost of using a surgical robot,” said Restore CEO Clif Parker. “Our recent clearance is a break-through for robotic instrument re-use as the instrument cleared for remanufacturing is the most used robotic instrument in US hospitals.”

“Encore was founded on the idea of instrument stewardship—we need to treat instruments as assets to keep costs down and protect the environment,” added Encore President and chief operating officer Tom Milano. “Restore Robotics and Encore’s collaboration on robotic instrumentation is a great win for resource stewardship.”