Point Robotics MedTech's Point Kinguide system received FDA 510(k) clearance.
It is Taiwan's first FDA-cleared surgical robot and the first handheld robot with a parallel manipulator for orthopedics, the company said Aug. 11. The robot has a handheld drilling system and navigation system to assist surgeons during implant surgery.
Point Robotics plans to expand indications for other spine cases including herniated disc decompression.