DePuy Receives Clearance for Ortho Robotic System

With the January 14, 2021 FDA 510(k) clearance of its orthopedic robotic system, Johnson & Johnson joins its competitors, Stryker, Zimmer Biomet and Smith & Nephew with its own robotic offering for large joint surgery.

The clearance of Johnson & Johnson subsidiary DePuy Ireland UC's VELYS Robotic-Assisted Solution is for total knee arthroplasty. The company says it plans to seek future clearances for use in hip and shoulder arthroplasty surgeries.

The company submitted its clearance notification on September 21, 2020 and received clearance on January 14, 2021.

VELYS System for ATTUNE

A company spokesperson told OTW that the VELYS system has been designed for use with the DePuy Synthes ATTUNE Total Knee System, and its current cleared indication for use includes the ATTUNE Fixed Bearing Technology. Additional regulatory submissions will follow for use of the VELYS Robotic Assisted Solution in other ATTUNE Knee System applications.

At a medical investor meeting in November, the company highlighted features of the system, which include imageless robot, requiring no CT, MRI, or X-ray for pre-operative imagining; direct attachment to the side rail of the patient's bed, and real time tracking of the patient's knee anatomy via an infrared camera.

Wells Fargo analysts note the imageless feature is similar to Smith & Nephew's Blue Belt, while Stryker's Mako requires CT and Zimmer Biomet’s ROSA can use both X-ray, CT, or can be image-free.

According to the company, the intra-operative registration to determine the mechanical axis of the knee and to calculate the size of the implant components takes only a few minutes. The system does not have haptically constrained boundaries similar to ROSA and unlike Mako. Instead, it is a surgeon-driven system that allows the surgeon to upload a surgical plan, if needed. Once the plan is locked in, the robot provides a plane for the surgeon to execute the cut.

The analysts wrote that the company told investors that its system has advantages over competitor systems, in that the system is "highly efficient, it is not disruptive to the surgeon’s workflow, has a short set-up time, and a short learning curve." The analysts added the VELYS is "well-suited" for the ambulatory surgery center due to its small footprint, is expected to be a "cost-effective option" and is "easy to use." The company believes other first generations systems on the market are much larger, not as efficient, not connected digitally, and offer less ease of use than the VELYS.

Key Features

Other key features noted on the company website, include:

• Proprietary technology maintains the saw cut plane to help execute precise, reproducible surgeon-controlled cuts.
• Clear interface streamlined clinical application, adaptable workflow and fast registration process.
• Instrumentation and an easily maneuverable robotic design.
• Pre-resection assessment of alignment and predicted gap balance to help surgeons plan for optimal implant position.
• Single-page planning to easily adjust parameters helping surgeons personalize alignment and balance relative to soft tissues.
• Soft tissue stability graph provides balancing data throughout the full range of motion prior to execution of bony cuts.
• High-speed camera, triple-drive motion technology, and PURESIGHT hydrophobic optical reflectors.
• Post-resection assessment to help surgeons verify final gap balance and overall leg alignment for intra-operative confirmation of implant position.

To request more information from the company, click here.