Spineart and eCential Robotics receive FDA 510(k) clearance for the PERLA® TL application for use with eCential® Op.n® navigation system for robotic procedures.

GENEVA, Aug. 26, 2026 /PRNewswire/ -- Spineart, a global fast-growing company in spine surgery innovation, and eCential Robotics today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the PERLA® TL application (PERLA® by Spineart app) for use with the eCential® Op.n® Navigation and Robotic-Assisted Platform.

Building on the previously established compatibility between PERLA® and the Op.n® navigation platform, the FDA clearance now extends the solution to robotic-assisted workflows. This advancement enables surgeons to leverage integrated navigation and robotics technologies to support implant placement accuracy, workflow efficiency, and procedural confidence in both open and minimally invasive spine procedures.

This milestone represents a significant advancement in Spineart's strategy to deliver a comprehensive enabling technologies ecosystem and provides surgeons with high navigation and robotic-assisted capabilities when using the PERLA® TL Open and MIS pedicle screw systems.

The PERLA® app will operate seamlessly on the Op.n® platform, bringing together implant technology, real-time navigation, and robotic assistance within a unified workflow designed to support consistent procedural execution and high standards of patient care.

"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", said Laurent Nodé-Langlois, Chief Technology Officer at Spineart.

"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," said Lisa Jacobs, President, North America at eCential Robotics.

As hospitals and surgeons increasingly adopt navigation and robotic-assisted technologies, this addition further strengthens Spineart's comprehensive portfolio of spine technologies and reinforces the company's commitment to providing surgeons with innovative solutions backed by clinical evidence, global experience, and a relentless focus on patient outcomes.

Starting today, the PERLA® App will be displayed in Dallas (TX) in the Spineart Innovation Center, alongside other technologies and products currently available in Spineart's comprehensive Spine portfolio. Contact us to schedule a demo: Contact - Spineart

SOURCE Spineart