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..
FDA 510(k) Cleared Orthopedic Augmented Reality Devices (Product Code SBF)
About Product Code SBF - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code SBF since 2019, with 42 receiving FDA clearance (average review time: 144 days).
Submission volume has increased in recent years - 19 submissions in the last 24 months compared to 14 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under SBF have taken an average of 115 days to reach a decision - down from 168 days historically, suggesting improved FDA processing for this classification.
SBF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →