Authors: Ruben D. Salas Parra MD and David Pechman MD, FACS
Moon Surgical, a French-American based company, received Food Drug and Administration (FDA) 510(k) approval for its Maestro surgical robotics system on December 6, 2022.
Moon Surgical developed the minimalistic Maestro system as a two-armed robotic surgical assistant that can aid a surgeon by holding or manipulating tissues in laparoscopic surgery. The system was designed to be more flexible and affordable than other currently-available robotic platforms. The system is placed opposite the surgeon and provides the surgeon with two arms that can be manually moved and locked in place. It is compatible with standard laparoscopic cameras and instruments.
Moon Surgical announced the completion of a 30-patient trial using the Maestro robotic platform performed by Dr. Guy-Bernard Cadière at CHU Saint-Pierre, a public university hospital in Belgium. Dr. Cadière safely performed cholecystectomies, bariatric surgeries, hernia repairs, colorectal surgeries and antireflux surgeries, all without an assistant.
The FDA determined this device is substantially equivalent to a predicate device: the ENDEX Endoscopic Positioning System (K936308).
The Maestro system is intended to hold and position laparopic cameras and instruments in laparopic surgical procedures.
The Maestro system is contraindicated in any procedure where laparoscopic surgery is unsafe or otherwise contraindicated.
