510(k) FDA clearance of the VELYS Robotic-assisted solution for use in unicompartmental knee athroplasty procedures – DePuy Synthes

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 procedures1, 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 cla.

learning curve and variability in outcomes. Achieving precise alignment and optimal implant placement is paramount for long-term success, and the ability to do so in a reproducible manner continues to be an unmet need in the UKA space9-10,” said Dr. John Redmond, orthopedic surgeon performing both knee and hip procedures in Jacksonville, FL.† “The VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty will enable a more personalized procedure that helps drive reproducible outcomes, while insights delivered from its planning and balancing tools will enable better precision and accuracy11. I am excited to see it utilized for UKA procedures and particularly in the ambulatory surgery center setting where its smaller footprint and image-free technology will enable greater operational efficiency.”

Key features of the VELY™ Robotic-Assisted Solution for UKA include : i.The single PROADJUST™ PLANNING SCREEN enables personalized planning to help ensure precise implant placement, alignment, and balance relative to soft tissue ii. An ACCUBALANCETM GRAPH for personalized balancing throughout the full range of motion. iii. Compatibility with the SIGMA HP Unicondylar Knee System that has been demonstrated to improve 12-year survivorship compared with its class. iv. Complete UKA workflow with UKA-specific functionality.