DePuy Synthes Gains FDA Clearance for VELYS Robot with ATTUNE Knee

By Julie A. Vetalice

DePuy Synthes Gains FDA Clearance for VELYS Robot with ATTUNE Knee

DePuy Synthes received FDA 510(k) clearance to market the VELYS™ Robotic-Assisted Solution for use with the ATTUNE® Total Knee and its cleared indications for use. The company plans to extend the system across adjacent platforms such as hips and shoulders.

The table-mounted system provides the following benefits:

  • Gap balance data to help surgeons visualize and predict joint stability
  • Instinctive, integrated design to give the surgeon control while optimizing O.R. flow
  • Accurate, consistent plan execution supporting the ATTUNE Total Knee in providing better patient outcomes

DePuy Synthes submitted the robotic-assisted component of VELYS to FDA in September 2020, entering a market alongside competitor systems like Stryker’s Mako platform, Zimmer Biomet’s ROSA and Smith+Nephew’s CORI robot.

The VELYS Robotic-Assisted Solution was designed from proprietary technology developed by Orthotaxy, developer of software-enabled surgery technologies acquired by Johnson & Johnson Medical Devices Companies in 2018.

"Coupled with the ATTUNE Total Knee, the VELYS Robotic-Assisted Solution is highly differentiated and can help improve clinical outcomes and increase patient satisfaction, providing a more attractive clinical solution to current options on the market," said Aldo Denti, Company Group Chairman. "With the addition of the VELYS Robotic Assisted Solution to our VELYS Digital Surgery Platform, we are continuing our vision to be the most personalized and connected orthopaedics company."

Product Labels: Knee Replacement, Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory