Spineart and eCential Robotics Receive FDA Clearance for PERLA TL Spine App

Aug 26, 2026
Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA TL application for use with the eCential Op.n navigation and robotics platform.

Spineart and eCential Robotics said in a press release that the U.S. FDA granted 510(k) clearance for the PERLA TL application for use with the eCential Op.n navigation and robotics platform.

The clearance adds robotic workflow use for PERLA TL, which was already compatible with the Op.n navigation platform. The system is intended to support placement of PERLA TL Open and MIS pedicle screw systems in open and minimally invasive spine procedures.

The PERLA app runs on the Op.n platform and combines Spineart implant technology with eCential Robotics navigation and robotic assistance. The companies said the app will be displayed at the Spineart Innovation Center in Dallas.

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