JnJ Orthopaedics Company DePuy Synthes gets 510(k) FDA clearance of VELYS Robotic-Assisted Solution for use in Unicompartmental Knee Arthroplasty Procedures

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.

“We are committed to continually improving and expanding the capabilities and user experience of our VELYS Enabling Technology portfolio,” said Aldo Denti, Company Group Chairman, DePuy Synthes. “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. 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.”

Unicompartmental knee arthroplasty, otherwise known as partial knee replacement, offers potential for bone preservation and shortened recovery periods. UKA utilization offers clinical benefits and greater economic efficiency for patients, providers and payors compared to TKA. Despite the benefits, UKA is underutilized due to complexities that include smaller incisions and lack of visibility.

Robotics has the opportunity to overcome many of the challenges surgeons face in manual partial knee replacement when they are designed to provide intra-operative insights, more accurate implant alignment and positioning, and more reproducible and consistent outcomes.

“Challenges associated with partial knee replacement include lack of access and visibility, which can lead to a longer 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 space,” 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 accuracy. 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 VELYS Robotic-Assisted Solution for UKA include:

• The single PROADJUST PLANNING SCREEN enables personalized planning to help ensure precise implant placement, alignment, and balance relative to soft tissue.
• An ACCUBALANCE GRAPH for personalized balancing throughout the full range of motion.
• Compatibility with the SIGMA HP Unicondylar Knee System that has been demonstrated to improve 12-year survivorship compared with its class.
• Complete UKA workflow with UKA-specific functionality.

The system will be featured at the Annual Meeting of the American Association of Hip and Knee Surgeons in November. Details on commercial availability will be forthcoming.