DePuy Synthes receives 510(K) FDA Clearance for Robotic-Assisted Solution

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January 19, 2021

The Johnson & Johnson Medical Devices Companies announced that DePuy Synthes has received 501(k) clearance from the U.S. Food & Drug Administration (FDA) for its VELYS Robotic-Assisted Solution, designed for use with the ATTUNE Total Knee System and its cleared indications for use. The solution will become part of the broader VELYS Digital Surgery Platform of connected technologies, the company said.

The VELYS system is a table-mounted solution, with a design that can integrate into any operating room, the company said. It adapts to the surgeon’s workflow, and is designed to give them the control they are used to, and helps them execute more bony cuts. In addition, the system features advanced planning and a next-generation design to accurately resect bones that align and position the implant relative to the soft-tissue during total knee replacement without the need for pre-operative imaging.

“I’ve used the VELYS Robotic-Assisted Solution in several of my ATTUNE Knee procedures and have found [it] to be accurate, fast and efficient,” said Dr. Mark Clatworthy, an orthopedic surgeon at MercyAscot Hospital in Auckland, New Zealand. Dr. Clatworthy was the first to perform a knee procedure using the VELYS system. “The device enables me to evaluate the bony anatomy and soft tissue envelope of the knee to plan the optimal implant position and then use the robotic-assisted solution to deliver and execute the plan. I’ve found my knees to be well balanced at the end of the procedures, and my patients are doing well post-operatively.”

“Globally, previous generation robotics have only penetrated key orthopedic segments between 5 to 10% of the market. A significant opportunity for combined robotic and digital surgery exists,” said Aldo Denti, company group chairman of the DePuy Synthes franchise. “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 orthopedics company.”

The system was designed from proprietary technology developed by Orthotaxy, a privately-held developer of software-enabled surgery technologies acquired by Johnson & Johnson Medical Devices Companies in 2018.

More details on the VELYS Digital Surgery System are available here. For information on the ATTUNE Knee system, visit its website here.

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