Johnson & Johnson MedTech has secured an FDA 510(k) clearance for its first robotically guided platform for spine surgery and has slated its commercial launch for the first half of next year.
The DePuy Synthes division’s Velys Spine system is designed to offer what the company describes as active robotic assistance. Instead of using a fixed arm to help steady the placement of a drill, screw or implant, J&J’s approach aims to track and keep pace with any unintentional patient movement—including shifts in the spine itself mid-procedure—as well as adapt to the surgeon’s personal preferences.
“We believe that the unique features and capabilities of active robotics technology will set a new standard in surgical care for spine patients everywhere,” Russell Powers, worldwide president of DePuy Synthes’ spine business, said in a statement.
The system—developed through a collaboration with French company eCential Robotics—can also be used solely as a standalone navigation aid. Velys Spine is cleared for use in planning and performing spinal fusion procedures across the backbone’s cervical, thoracolumbar and sacroiliac sections.
In terms of implants, Velys Spine will be used with DePuy Synthes’ core catalog of products, including the TriALTIS portfolio and its navigation-enabled instruments that received a clearance from the FDA last October. It includes a posterior, thoracolumbar pedicle screw system in addition to drills, taps and screwdrivers that can be used manually or with powered robotic assistance.
The latest addition to the Velys robot family also follows a separate FDA green light handed down in June for its knee-focused platform, which expanded that system’s use into partial joint replacements.
Also known as unicompartmental knee arthroplasties, J&J said the procedure has been underutilized in robotics due to the complexity that comes with smaller incisions and less vision into the joint. The Velys platform is also used in orthopedic hip and shoulder procedures.
Elsewhere, earlier this week Stryker’s leadership set up the launch of its own spine surgery system for the fourth quarter of this year, through its Mako line of robotic assistants. The company received an FDA clearance for its Q Guidance System, which includes digital safety zones for bone resection.