Geneva, Switzerland , Aug 26, 2026

Spineart and eCential Robotics have announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the PERLA® TL application for use with the eCential® Op.n® Navigation and Robotic-Assisted Platform. The regulatory milestone extends the established compatibility between Spineart’s PERLA® technology and the Op.n® navigation platform to include robotic-assisted spine surgery workflows. The companies said the clearance enables surgeons to combine implant technology, real-time navigation and robotic assistance within a unified workflow for both open and minimally invasive spine procedures. The PERLA® TL application is designed for use with Spineart’s PERLA® TL Open and MIS pedicle screw systems, supporting implant placement and procedural execution through integrated navigation and robotics capabilities. The clearance represents a further step in Spineart’s strategy to develop an enabling technology ecosystem for spine surgery and strengthens the collaboration between the two companies in advancing navigation-assisted and robotic-assisted surgical procedures.

FDA Clearance Expands PERLA® Robotic Workflows

The newly cleared application builds on the previously established compatibility between the PERLA® application and eCential’s Op.n® navigation platform. With the FDA 510(k) clearance, the solution can now be incorporated into robotic-assisted workflows, bringing additional capabilities to surgeons performing spinal procedures. The integrated system combines real-time surgical navigation with robotic assistance, with the companies positioning the technology to support implant placement accuracy, workflow efficiency and procedural confidence. The PERLA® app is intended to operate directly on the Op.n® platform, creating a unified environment in which surgeons can access implant-related technology alongside navigation and robotic capabilities. The approach is designed to support both open and minimally invasive spine surgery, areas in which accurate placement of pedicle screws is an important component of procedural execution. By combining these technologies within one workflow, Spineart and eCential Robotics aim to provide surgeons with a more integrated approach to technology-assisted spine procedures while maintaining focus on consistency and patient care.

Spineart and eCential Advance Surgical Robotics

The FDA clearance also highlights the companies’ broader collaboration around open robotic platforms for spine surgery. Spineart contributes its expertise in spinal implants and surgical technologies, while eCential Robotics provides its navigation and robotics platform. The companies said their collaboration has resulted in a workflow that brings together Spineart’s implant systems and eCential’s navigation and robotic technology. The PERLA® application’s integration with the Op.n® platform is intended to provide surgeons with access to navigation and active robotic assistance without requiring separate technology workflows. Spineart described the development as part of its commitment to building a comprehensive ecosystem of enabling technologies for spine surgery. The companies are also emphasizing the potential of integrated navigation and robotics to support precision, procedural efficiency and consistency as hospitals and surgeons increasingly adopt technology-assisted surgical approaches. The regulatory clearance provides an important U.S. milestone for this strategy and enables the PERLA® TL application to be used with the Op.n® platform for cleared robotic-assisted procedures.

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Robotic Technology Targets Spine Surgery Needs

The development comes as hospitals and surgeons increasingly explore robotic-assisted and navigation-guided technologies for complex spinal procedures. Spineart said the addition of robotic compatibility further strengthens its portfolio of spine technologies and supports its focus on solutions backed by clinical evidence, global experience and patient outcomes. The PERLA® application will be demonstrated at the Spineart Innovation Center in Dallas, Texas, alongside other technologies and products in the company’s spine portfolio. The FDA 510(k) clearance does not represent approval of an entirely new robotic platform but rather extends the cleared use of the PERLA® TL application to the eCential Op.n® Navigation and Robotic-Assisted Platform. This distinction is important as the technology moves into broader clinical use. By integrating implant planning and placement support with real-time navigation and robotic assistance, the companies are seeking to simplify technology-enabled spine procedures and provide surgeons with additional tools for consistent execution. The latest regulatory milestone therefore reinforces the growing role of robotics and image-guided navigation in spine surgery while marking continued progress in the collaboration between Spineart and eCential Robotics.

Source: Spineart press relese