Blueprint Patient-Specific Instrumentation

Blueprint Patient-Specific Instrumentation is a software and hardware system for surgeons to plan shoulder replacement surgery and shoulder instability treatment. It uses CT scan images to allow surgeons to visualize, measure, and reconstruct shoulder anatomy, then design patient-specific surgical guides and glenoid components based on the preoperative plan.

Key technological differences include algorithm improvements for glenoid premorbid prediction and shoulder instability planning, expanded auto-planning for reverse shoulder arthroplasty, a new non-nominal case detection algorithm based on deep learning, and compatibility with additional cleared devices (Humeral System Fracture K220914 and Tornier HRS Line extension K241878).

Not stated in this summary. The document references ISO 13485 for quality management system requirements but does not cite specific performance testing standards or consensus standards for the device's functionality.

The subject device hardware is identical to the predicate device (BLUEPRINT Patient Specific Instrumentation K241491). Software differences are supported by verification and validation testing including functional testing, compatibility testing for new implant integration, and validation of anatomical measurements and planning features. These technological differences do not raise new safety or effectiveness questions and are addressed through performance testing.