J&J’s DePuy Synthes wins new FDA clearance for Velys surgical robot

Johnson & Johnson MedTech‘s DePuy Synthes announced today that it received a new FDA 510(k) clearance for […]

Johnson & Johnson MedTech‘s DePuy Synthes announced today that it received a new FDA 510(k) clearance for its Velys surgical robot platform.

The FDA cleared Velys for the clinical application of unicompartmental knee arthroplasty (UKA). This builds upon the Velys platform used in total knee arthroplasty (TKA), which the FDA cleared in January 2021.

DePuy Synthes designed its UKA application for both medial and lateral procedures. It enables surgeons to guide precise implant placement without a CT scan. The application has compatibility with the Sigma HP unicondylar knee system with the new, reusable Intuition instruments.

UKA — or partial knee replacement — helps preserve bones and shorten recovery periods. However, according to DePuy Synthes, its underutilization comes as a result of complexities like smaller incisions and a lack of visibility. Robotic platforms like Velys can helpt o overcome those challenges with intraoperative insights, accurate implant alignment and positioning and more reproducible and consistent outcomes.

Key features of Velys for UKA include a single ProAdjust planning screen for personalized planning. It helps to ensure precise implant placement, alignment and balance relative to soft tissue. The system also has an AccuBalance graph for personalized balancing throughout the full range of motion.

DePuy Synthes plans to feature the system at the Annual Meeting of the American Association of Hip and Knee Surgeons in November. It expects details on commercial availability soon.

“We are excited to add a robotic-assisted offering with our clinically proven implant for UKA which we believe will address some of the key unmet needs in the partial knee replacement segment, including accuracy and simplicity, that other systems on the market do not fully address,” said Aldo Denti, group chair, DePuy Synthes. “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.”

Original article (https://www.massdevice.com/depuy-synthes-velys-surgical-robot-new-fda-clearance/)