VELYS™ Hip Navigation

VELYS™ Hip Navigation is software that assists surgeons in positioning total hip replacement components during surgery by measuring component positions relative to bone structures identified on X-ray or fluoroscopy images. It also helps with preoperative planning and postoperative analysis for hip and knee replacement procedures by overlaying prosthesis templates on radiological images.

The main technological difference from the predicate device (JointPoint) is the addition of a machine learning model that provides default positioning of anatomical landmarks, which the surgeon can then confirm or adjust. Both devices use the same preoperative and intraoperative workflows, operate on Windows and iOS, and provide identical outputs including leg length, offset, inclination, and anteversion measurements.

The document references 21 CFR Part 820 (Quality Management System Regulation), ISO 13485 clauses for design controls and nonconforming product management, and FDA-consensus standards where available. Specific consensus standards are not explicitly named.

Both devices have identical intended uses, indications for use, and similar technological characteristics for assisting in total hip replacement positioning. Performance testing demonstrated that machine learning model outputs fell within the range of manual operator outputs for all five key measurements (leg length, femoral offset, total offset, cup inclination, and cup anteversion), showing no new questions of safety or effectiveness were raised by the ML feature addition.