Spineart wins FDA 510(k)

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.

August 26, 2026
1:17 pm

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.

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.

Sign up for Blog Updates