510(k) FDA clearance for J&J company DePuy Synthes for its robotic-assisted solution for knee arthroplasty

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Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has received 510(k) FDA clearance for the clinical application of the VELYS Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty (UKA). The expanded indication builds upon the VELYS Robotic-Assisted Solution platform used in Total Knee Arthroplasty (TKA), which has been cleared for use in 20 markets and utilized in over 55,000 procedures, equipping surgeons with the information needed to help preserve the soft tissue envelope, predict joint stability and work toward returning knee function. 

The UKA application is designed for both medial and lateral procedures and will enable surgeons to guide precise implant placement without a CT scan. It is compatible with the SIGMA HP Unicondylar Knee System with the new reusable INTUITION INSTRUMENTS. The SIGMA HP Implant demonstrates improved 12-year survivorship compared to class as shown in a national joint registry.

Aldo Denti, Company Group Chairman, DePuy Synthes said “Data and analytics will continue to serve as the backbone of our platform, which reveals real-time, actionable insights for surgeons to empower patient-specific operative decisions with the goal to improve outcomes and deliver personalization at scale."

Key features of the VELYS Robotic-Assisted Solution for UKA include single PROADJUST PLANNING SCREEN enabling personalized planning to help ensure precise implant placement, ACCUBALANCE GRAPH for personalized balancing throughout the full range of motion. Details on commercial availability will be forthcoming.