JnJ Orthopaedics Company DePuy Synthes gets 510(k) FDA clearance of VELYS Robotic-Assisted Solution for use in Unicompartmental Knee Arthroplasty Procedures
Palm Beach Gardens: Johnson & Johnson MedTech has announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, 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 over 55,000 procedures, equipping surgeons with the information needed to help preserve the soft tissue envelope, predict joint stability and work toward returning knee function.
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.”
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