The FDA has recognized multiple robots and navigation systems made for spine and orthopedic surgeries in 2022.
1. Surgalign Holdings received FDA 510(k) clearance for its Holo Portal surgical system for lumbar spine surgeries. Holo Portal is described as the first artificial intelligence-driven augmented reality guidance system for spine surgery.
2. Stryker's Q guidance system received FDA 510(k) clearance for spine surgery applications. The Q system is designed for advanced surgical planning and intraoperative guidance for open or percutaneous computer-assisted surgery.
3. VisAR, an augmented reality surgical guidance system, received FDA clearance for intraoperative spine surgery. The system transforms imaging data into a 3D hologram that is visible and superimposed on the patient.
4. MicroPort Navibot has received FDA 510(k) clearance of its first robot-assisted platform for orthopedic use. The Skywalker system will initially be used for total knee replacements and is compatible with the Evolution medial-pivot total knee system.
5. 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.