In March 2025, Restore Robotics, a remanufacturer of Intuitive Surgical’s EndoWrist Monopolar Curved Scissors received the first FDA 510(k) clearance for a X/Xi instrument. In FY24, Instruments & Accessories accounted for ~60% of Intuitive's revenue and we estimate ~70% of operating income.
We have interviewed ~10 instrument remanufacturers, distributors and former Intuitive Surgical sales executives to understand the potential impact remanufacturing may have on Intuitive's earning power.
There is a long history of Independent Service Operators (ISOs) and Independent Repair Companies (IRCs) attempting to offer aftermarket services for Da Vinci robots and instruments. Intuitive has leveraged its scale and market power to exclude third-parties from the market that has led to multiple antitrust lawsuits:
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