eCential Op.n adds FDA-cleared PERLA TL robotic workflow
Spineart received FDA 510(k) clearance for robotic instruments and software designed for use with eCential Robotics’ Op.n navigation and robotic-guidance platform.
Why it matters
The clearance expands the existing Op.n navigation workflow into robot-assisted use with Spineart’s PERLA TL instrumentation.
Evidence notes
- FDA submission K261205 was cleared on July 29, 2026 and covers open, minimally invasive and percutaneous pedicle-screw procedures.
- The robotic reusable instruments couple Spineart PERLA TL screwdrivers and taps to a robotic adaptor for use in navigation or robotic-guidance mode.
- The cleared workflow is limited to Spineart implants included in the Perla by Spineart software and uses eCential’s separately cleared Op.n platform.
Company context
eCential Robotics designs an open, modular surgical platform for bone procedures. The Grenoble company integrates intraoperative 2D/3D imaging, navigation and robotic guidance so implant partners and hospitals can use a unified operating-room workflow.