Spineart’s PERLA TL App Gains FDA Clearance for Robotic Spine Surgery

Spineart and eCential Robotics received FDA 510(k) clearance on August 26, 2026 for Spineart’s PERLA TL application to run on eCential’s Op.n navigation and robotic-assisted platform, extending a previously navigation-only pairing into robotic-assisted workflows. The clearance covers the PERLA TL Open and MIS pedicle screw systems in both open and minimally invasive spine procedures, the companies said in their joint announcement.

The clearance changes what the PERLA app does on the Op.n platform. The two systems were already compatible for navigation, where the platform tracks instruments and implants against patient imaging while the surgeon’s hands do the work. The new clearance extends the app into robotic-assisted workflows, in which the platform’s robotic arm guides execution of the surgical plan. The companies describe the combined workflow as bringing implant technology, real-time navigation, and robotic assistance into a single setup, aimed at supporting implant placement accuracy and workflow efficiency.

“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, in the announcement.

Lisa Jacobs, President of North America at eCential Robotics, framed the clearance as the product of a longer partnership: “Spineart has been a trusted partner and one of the first to believe in our vision for an open robotic platform. Together, we have created a seamless workflow that combines Spineart’s implant expertise with eCential’s navigation and robotics technology.”

A Partnership That Has Been Building Since 2022

The two companies have been working toward this point for nearly four years. Spineart and eCential Robotics announced their partnership in December 2022, agreeing to co-develop spine surgery applications and co-market eCential’s open robotic surgery platform. That was months after eCential’s platform first received FDA clearance for spine surgery in September 2022. A second 510(k) followed in July 2024 for the platform’s spine navigation and robotic-assistance device, and the world’s first surgeries using the open robotic platform for spine were completed that same month, according to eCential’s news archive.

The platform’s next generation, Op.n GEN 1, received its own FDA 510(k) clearance in March 2025. The app ecosystem around it has grown in parallel: ChoiceSpine launched its own application for surgical use on the Op.n platform in June 2025, with eCential noting at the time that the ChoiceSpine app followed Spineart’s PERLA app. Nexxt Spine joined the ecosystem as a strategic partner in January 2026, and in February 2026 partner Amplitude Surgical performed its first robotic knee surgeries in Europe using its Andy robot, powered by eCential technology. The PERLA TL clearance fits Spineart’s stated strategy of building what it calls a comprehensive enabling technologies ecosystem around its implant portfolio.

How the Op.n Platform Works

eCential Robotics designs its platform as an all-in-one surgical system combining 2D/3D imaging, real-time navigation, and robotics for bone surgery. The company’s model is deliberately open: rather than locking the robot to one manufacturer’s implants, it hosts third-party applications, so implant companies like Spineart build apps that run on the shared platform. eCential reports more than 100 registered patents, more than 2,500 surgeries performed with its technology, and over 15 clinical and business partners. It operates from dual headquarters in Grenoble, France and Franklin, Tennessee.

The spine-robotics field has been active on the regulatory front elsewhere this summer. Momentis Surgical’s Anovo system gained FDA clearance for multiport surgery in July 2026, and Sentante’s endovascular robot entered commercial use in vascular surgery this month. The PERLA TL clearance adds robotic spine surgery to that run, and does so through the app-model route: the implant company’s software, the platform company’s robot, one regulated workflow.

Starting August 26, 2026, the PERLA app is on display at the Spineart Innovation Center in Dallas, Texas, alongside the rest of Spineart’s spine portfolio, with demos available by appointment.