J&J MedTech Subsidiary Gets FDA OK for Knee Surgery Robot

The expanded indication builds upon the VELYS Robotic-Assisted Solution platform used in Total Knee Arthroplasty.

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Johnson & Johnson MedTech announced that its orthopedics company, DePuy Synthes, 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 more than 55,000 procedures.

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.

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. 

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