Signature™ ONE System

The Signature™ ONE System is a computer-assisted surgical planning and guidance system for shoulder replacement procedures. It uses patient-specific CT images to create a pre-operative plan and manufactures 3D-printed guides and bone models to help surgeons accurately execute that plan during total shoulder arthroplasty in skeletally mature patients.

The device uses selective laser sintering (SLS) to manufacture polyamide guides and bone models from approved pre-surgical plans. Key updates include a retrained AI/ML model for automatic segmentation using production-grade scapula and humerus CT data, and additional configurable landmarks in the landmarking step. The overall software workflow, principle of operation, materials, and sterilization methods remain unchanged from the predicate device K232425.

IEC 62304 (Medical Device Software—Software Life Cycle Processes) and the FDA's Content of Premarket Submissions for Device Software Functions Guidance (issued June 14, 2023). Testing included performance tests, engineering analysis, usability engineering, and validation per the Enhanced Level of Documentation standard.

The subject device has the same intended use, indications, principle of operation, guides/bone models, and fundamental software workflow as predicate K232425. The improved AI/ML segmentation model and additional configurable landmarks are used in the same manner as the predicate and do not raise different safety or effectiveness questions. Therefore, the proposed device is at least as safe and effective as the predicate device.