Restore Robotics Expands FDA-Cleared Robotic Instrument Portfolio with Two Additional da Vinci Xi Clearances
Key Insights
Restore Robotics (search) received FDA 510(k) clearances for remanufacturing two additional da Vinci Xi (search) robotic surgical instruments, expanding its portfolio of cost-effective alternatives to new equipment.
The company aims to transform robotic surgery economics by enabling healthcare providers to significantly reduce costs while maintaining surgical performance and reliability standards.
Through partnership with Encore Medical Device Repair (search), the expanded remanufacturing program offers hospitals meaningful cost reductions, increased sustainability, and seamless workflow integration.
Restore Robotics (search) announced on March 31, 2026, that it has received additional 510(k) clearances from the U.S. Food and Drug Administration for the remanufacturing of two more da Vinci Xi (search) robotic surgical instruments. This regulatory milestone expands the Henderson, Nevada-based company's growing portfolio of cleared instruments and strengthens its position as a leader in robotic instrument remanufacturing.
The latest clearances advance Restore Robotics (search)' mission to provide hospitals and surgery centers with cost-effective, high-quality, and sustainable alternatives to purchasing new robotic instruments from original equipment manufacturers.
Economic Impact on Robotic Surgery
"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 (search). "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."
The expanded product offering allows hospitals to capture greater savings across a broader portion of their robotic instrument spend through the company's established partnership with Encore Medical Device Repair (search) for nationwide distribution.
Program Benefits for Healthcare Providers
Hospitals participating in the Restore Robotics (search) remanufacturing program benefit from meaningful cost reductions versus original equipment manufacturer instruments, increased sustainability through instrument reuse, and seamless integration into existing robotic surgery workflows.
"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."
Regulatory Framework and Industry Partnership
Intuitive Surgical, Inc. has granted approval under its contracts for Restore Robotics (search) to remanufacture any EndoWrist that falls under the scope of any 510(k) clearance from the FDA. The company operates independently from Intuitive Surgical while maintaining compliance with regulatory requirements for remanufactured medical devices.
Restore Robotics (search) operates a state-of-the-art facility in Henderson, Nevada, delivering FDA-cleared solutions that enhance affordability and sustainability in robotic-assisted surgery. Encore Medical Device Repair (search), founded on the principle that medical device reuse should play a central role in responsible healthcare, focuses on high-value, high-utilization instruments to deliver industry-leading service, quality, and cost savings to healthcare providers.