Spineart and eCential Robotics have received FDA 510(k) clearance for Spineart's PERLA TL application to run on eCential's Op.n navigation and robotic-assisted platform, the companies said on August 26. The clearance covers the PERLA TL Open and MIS pedicle screw systems in both open and minimally invasive spine procedures.
From Navigation-Only To Active Robotic Workflow
The two systems were already compatible for navigation, where the platform tracks instruments and implants against patient imaging while the surgeon executes the plan. The new clearance extends the PERLA app into robotic-assisted workflows, letting the Op.n platform's robotic arm guide execution of the surgical plan itself. The companies describe the combined workflow as folding implant technology, real-time navigation and robotic assistance into a single setup aimed at improving screw placement accuracy and operating room throughput.
A Partnership That Has Been Building Since 2022
Spineart and eCential first announced their co-development and co-marketing partnership in December 2022. eCential's platform received its initial FDA clearance for spine surgery in September 2022, followed by a second 510(k) in July 2024 for the spine navigation and robotic-assistance device and the world's first surgeries on the open robotic platform for spine. Op.n GEN 1 was cleared in March 2025, ChoiceSpine's app followed in June 2025, and Nexxt Spine joined as a strategic partner in January 2026. In February 2026, partner Amplitude Surgical performed its first robotic knee surgeries in Europe using its Andy robot, powered by eCential technology.
Adds To A Busy Summer For Surgical Robotics
Laurent Nodé-Langlois, Chief Technology Officer at Spineart, called the milestone a step toward "a truly collaborative robotic platform" that combines simplicity, precision and active robotics for spine surgeons. eCential North America president Lisa Jacobs framed the clearance as the product of a longer partnership around an open robotic platform. Starting August 26, the PERLA app is on display at the Spineart Innovation Center in Dallas alongside the rest of the company's spine portfolio, with demos available by appointment.
The clearance lands during a busy stretch for surgical robotics, including recent regulatory wins and rollouts covered by TRM, from FDA-cleared AI medical device outcome data to FANUC's latest collaborative robot.
Reporting based on coverage from Unite.AI and PR Newswire.