DePuy Synthes, the orthopaedics company of Johnson & Johnson (J&J), has received the US Food and Drug Administration (FDA) 510(k) approval for its VELYS robotic-assisted solution.
VELYS solution is already approved in the US and twenty other markets for total knee arthroplasty (TKA) procedures and was used in more than 55,000 TKA procedures.
The current FDA approval expands its applications to include unicompartmental knee arthroplasty (UKA) procedures, both medial and lateral.
VELYS solution is compatible with the Sigma HP Unicondylar Knee System and new reusable Intuition Instruments, helping surgeons guide precise implant placement without a CT scan.
DePuy Synthes group chairman Aldo Denti said: “We are committed to continually improving and expanding the capabilities and user experience of our VELYS Enabling Technology portfolio.
“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.”
UKA, also known as partial knee replacement, offers the potential for bone preservation and shortened recovery periods and is underutilised due to several complexities.
DePuy Synthes said that robotics will address the challenges through intra-operative insights, accurate implant alignment and positioning, and consistent outcomes.
Its VELYS robotic-assisted solution features a single Proadjust Planning Screen to ensure precise implant placement, alignment, and balance relative to soft tissue.
Also, it comes with an Accubalance Graph feature for personalised balancing throughout the motion and provides complete UKA workflow with UKA-specific functionality.
Jacksonville orthopaedic surgeon John Redmond said: “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.
“The VELYS Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty will enable a more personalised procedure that helps drive reproducible outcomes, while insights delivered from its planning and balancing tools will enable better precision and accuracy.”
