FDA Clears Two More Remanufactured da Vinci Xi Instruments

Restore Robotics expands its FDA-cleared da Vinci Xi portfolio, giving US hospitals a lower-cost alternative for robotic instruments

24 Apr 2026

Restore Robotics has secured FDA 510(k) clearance for the remanufacturing of two additional da Vinci Xi robotic surgical instruments, the permanent cautery hook and the permanent cautery spatula. Announced on March 31, 2026, the milestone brings the Henderson, Nevada-based company's total portfolio of cleared remanufactured da Vinci Xi instruments to four.

The clearances take direct aim at one of the sharpest cost pressures in US robotic surgery: the price of instruments sourced exclusively from original equipment manufacturers. With FDA-cleared alternatives now available across a broader range of high-utilization tools, hospitals and ambulatory surgery centers can capture meaningful savings without replacing their existing robotic platforms.

Restore Robotics distributes its remanufactured instruments nationally through its established partnership with Encore Medical Device Repair. The expanded product range allows facilities with high robotic surgery volumes to reduce costs across more of their instrument spend, compounding the financial benefit over time.

The development reflects a wider shift in how surgical facilities are approaching instrument procurement. Remanufacturing was once viewed with operational skepticism, but expanding FDA clearances are changing that calculus. Restore Robotics holds the only FDA clearance in the US to remanufacture da Vinci Xi instruments, and each new addition to its cleared portfolio strengthens the financial and regulatory case for facilities considering the switch.

For OR leaders weighing robotic surgery costs against outcomes quality, the growing remanufacturing market offers a practical, compliance-backed option. The question now is not whether remanufactured instruments belong in the OR, but how quickly procurement teams move to take advantage of them.