Spineart, eCential Robotics Win FDA Nod for PERLA TL Robotic Use

Spineart and eCential Robotics have received U.S. Food and Drug Administration (FDA) 510(k) clearance for Spineart’s PERLA TL application for use with the eCential Op.n navigation and robotic-assisted platform.

Building on PERLA’s compatibility with the Op.n navigation platform, the FDA clearance now expands the solution to robotic-assisted workflows. The integration combines implant technology, real-time navigation, and robotic assistance to support implant placement accuracy and workflow efficiency in open and minimally invasive spine procedures.

The PERLA app runs on the Op.n platform, enabling surgeons to use navigation and robotic-assisted capabilities with the PERLA TL Open and MIS pedicle screw systems as part of Spineart’s broader enabling technologies strategy.

Earlier this month, the company’s Baguera C cervical disc prosthesis obtained FDA approval for one and two contiguous levels.

Comments from Spineart and eCential execs

Laurent Nodé-Langlois, chief technology officer, Spineart: “This is an exciting milestone for our PERLA range and for our commitment to innovation in spine surgery. Together with eCential Robotics, we are introducing a truly collaborative robotic platform that brings simplicity, precision, and active robotics capabilities together to help redefine the surgical experience for spine surgeons and their patients.”

Lisa Jacobs, president, North America, eCential Robotics: “Spineart has been a trusted partner and one of the first to believe in our vision for an open robotic platform. We are incredibly grateful for the trust and collaboration they have brought to this journey. Together, we have created a seamless workflow that combines Spineart’s implant expertise with eCential’s navigation and robotics technology. This FDA clearance represents an important milestone for both organizations and demonstrates what is possible when two teams unite around a shared commitment to advancing spine surgery,”