Dive Brief:
- Restore Robotics, a company that remanufactures robotic surgical instruments, has received 510(k) clearance from the Food and Drug Administration for two additional Intuitive Surgical da Vinci Xi instruments, the company said this week.
- The instruments that won new clearances are the da Vinci Xi permanent cautery hook and permanent cautery spatula, Restore CEO Clif Parker told MedTech Dive in an email.
- The authorizations give Restore four clearances in total for da Vinci instruments, Parker said. Restore obtained clearance for da Vinci Xi 8 millimeter monopolar curved scissors in March 2025 and da Vinci Si 8 millimeter monopolar curved scissors in September 2022.
Dive Insight:
Intuitive Surgical’s da Vinci Xi is the world’s most widely used multiport robotic surgery system. The fourth-generation soft tissue robot preceded Intuitive’s latest model, the da Vinci 5, which has helped drive strong procedure growth for the company since its introduction in 2024.
The potential for instrument remanufacturing to erode Intuitive’s sales has been a concern among investors, but analysts have noted that the company has continued to outperform Wall Street’s forecasts despite the competition.
Restore said it is focused on providing hospitals and surgery centers with cost-effective, high-quality and sustainable alternatives to purchasing new robotic instruments from original equipment manufacturers.
“These additional FDA clearances mark another major step forward in our effort to transform the economics of robotic surgery,” Parker said in a statement. “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.”
Restore said it will continue to scale distribution of its remanufactured instruments nationwide through its partnership with Encore Medical Device Repair.
"Expanding the number of remanufactured robotic instruments available to hospitals is a natural progression in advancing responsible healthcare," Encore President and Chief Operating Officer Tom Milano said in a press release. "This continued collaboration represents a significant opportunity to improve both cost efficiency and environmental stewardship in surgical care."
