Restore Robotics Gains FDA OK to Remanufacture 2 More da Vinci Xi Robotic Instruments

Restore Robotics has obtained additional U.S. Food and Drug Administration (FDA) 510(k) clearances for remanufacturing of two more da Vinci Xi robotic surgical instruments.

The milestone grows the company’s portfolio of cleared instruments and bolsters its position as a leader in robotic instrument remanufacturing, Restore Robotics said. The company is continuing to deliver on its mission to offer hospitals and surgery centers with cost-effective, high-quality, and sustainable alternatives to buying new robotic instruments from OEMs.

The company first earned FDA clearance for remanufacturing Intuitive Surgical Da Vinci Xi monopolar scissors through its subsidiary Iconocare Health in March 2025.

“These additional FDA clearances mark another major step forward in our effort to transform the economics of robotic surgery,” said Clif Parker, CEO of Restore Robotics. “By expanding our remanufacturing capabilities across more high-utilization instruments, we are enabling healthcare providers to significantly reduce costs while maintaining the performance and reliability surgeons expect.”

Through an established partnership with Encore Medical Device Repair, the company will continue to scale distribution of its remanufactured instruments across the world. The expanded offering lets hospitals enjoy more savings in a broader portion of their robotic instrument spending.

“Expanding the number of remanufactured robotic instruments available to hospitals is a natural progression in advancing responsible healthcare,” said Tom Milano, president and COO of Encore. “This continued collaboration represents a significant opportunity to improve both cost efficiency and environmental stewardship in surgical care.”