DePuy Synthes Gains FDA Nod for VELYS Use in Partial Knee Replacement

Johnson & Johnson Orthopaedics company, DuPuy Synthes has received 510(k) FDA clearance for the clinical application of its VELYS Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty (UKA).
 
The UKA application is designed for medial and lateral procedures and will enable surgeons to guide precise implant placement without a CT scan^1-2. It is compatible with the SIGMA HP Unicondylar Knee System with Intuition instruments. 
 
VELYS expands on the VELYS Robotic-Assisted Solution platform used in Total Knee Arthroplasty (TKA), which provides surgeons with the information needed to help preserve the soft tissue envelope, predict joint stability, and work toward returning knee function³.
 
“We are committed to continually improving and expanding the capabilities and user experience of our VELYS Enabling Technology portfolio,” Aldo Denti, Company Group Chairman, DePuy Synthes told the press. “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.”

Key features of the VELYS Robotic-Assisted Solution 

• The single Proadjust planning screen enables personalized planning to help ensure precise implant placement, alignment, and balance relative to soft tissue.

• An Accubalancetm Graph for personalized balancing throughout the full range of motion.

• Compatibility with the SIGMATM HP Unicondylar Knee System that has been demonstrated to improve 12-year survivorship compared with its class. 

• Complete UKA workflow with UKA-specific functionality.

“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^4-5,” 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 accuracy⁶. 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.”
 
References
 
¹ DePuy Synthes VELYS Robotic-Assisted Solution for Unicompartmental Knee Rev C Surgical Technique Guide.
 
² DePuy Synthes VELYS Robotic-Assisted Solution for Unicompartmental Knee Summative Evaluation Report. December 2023. Windchill #103414383.

³ Hunter M., et al., Influence of Soft Tissue Releases on 2 Year Outcomes in Total Knee Arthroplasty and Rate of Soft Tissue Releases in Robotic-Assisted Surgery. Current Concepts in Joint Replacement, Dec 2022. Poster No P-124.
 
⁴ Begum FA, Kayani B, Morgan SDJ, Ahmed SS, Singh S, Haddad FS. Robotic technology: current concepts, operative techniques and emerging uses in unicompartmental knee arthroplasty. EFORT Open Rev. 2020;5(5):312-318. Published 2020 May 5. doi:10.1302/2058-5241.5.190089
 
⁵ Mittal, A., Meshram, P., Kim, W. H., & Kim, T. K. (2020). Unicompartmental knee arthroplasty, an enigma, and the ten enigmas of medial UKA. Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology, 21(1), 15. https://doi.org/10.1186/s10195-020-00551-x.
 
⁶ Doan G, Courtis P, Hoeffel D. Assessment of Accuracy of a Novel Image Free Robotic-Assisted System for Unicondylar Knee Arthroplasty, Poster 282. Presented at 4H World Arthroplasty Congress. Madrid, Spain. April, 2024.