FDA clears Spineart screws for robot-guided placement in the spine

The FDA granted 510(k) clearance on 26 August 2026 for Spineart’s PERLA TL application to run on the eCential Robotics Op.n Navigation and Robotic-Assisted Platform. It covers the PERLA TL Open and MIS pedicle screw systems in both open and minimally invasive spine procedures.

The two products were already cleared to work together, but only for navigation: the platform tracked instruments and implants against the patient’s imaging while the surgeon’s hands did the work. That clearance dates from March 2025. What the new one adds is the robotic arm — the platform can now guide execution of the surgical plan rather than only display where the instrument is relative to it.

Pedicle screws are placed into vertebrae within millimetres of the spinal cord and nerve roots, which is why this particular operation has drawn navigation and robotics earlier than most. The joint claim from both companies is accuracy of implant placement and workflow efficiency; neither release cites outcome data, and the clearance rests on substantial equivalence rather than a trial. Laurent Nodé-Langlois, Spineart’s chief technology officer, and Lisa Jacobs, eCential Robotics’ president for North America, both described it as a milestone for the partnership.