As of May 13, the FDA has cleared 882 artificial intelligence- and machine learning-enabled medical devices, including five orthopedic products.
The cleared devices have met the FDA’s applicable premarket requirements, including a focused review of each device's overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.
Note: The FDA's list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. Rather, it is a list of medical devices that incorporate AI/ML across medical disciplines.
The five orthopedic AI/ML-enabled medical devices cleared by the FDA:
Brainlab's Automatic Registration
Ortoma AB's OTS Hip
Enhatch's United Orthopedic Knee Patient-Specific Instrumentation
Brainlab's Spine Planning, Elements Spine Planning and Elements Planning Spine
NuVasive's Pulse System