FDA Product Code SBF: Orthopedic Augmented Reality

FDA product code SBF covers orthopedic augmented reality systems — an emerging category of surgical guidance technology.

These devices overlay preoperative imaging data onto the surgeon's real-time view of the patient through a head-mounted display or projection system, enabling visualization of bone anatomy, implant positioning, and surgical targets without looking away from the operative field. They represent an evolution beyond conventional navigation by eliminating the need for a separate monitor.

SBF devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Medacta International S.A., Mr Surgical Solutions, LLC and Augmedics, Ltd..