The 5 AI algorithms FDA-cleared for orthopedics


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

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