BETA
Open surgical navigation and robotic-guidance platform for spine and bone surgery.
eCential Robotics develops the Op.n platform, combining navigation, robotic assistance and operating-room imaging in an open ecosystem. Its model supports partnerships with implant manufacturers and procedure-specific applications, aiming to preserve surgeon choice across compatible workflows.
The company originated in Grenoble as Surgivisio and has U.S. headquarters in Franklin, Tennessee. FDA records document Op.n Navigation clearance in March 2025 and a further Spine Navigation and Robotic Guidance decision in July 2026. Partner platforms and knee-development programs are not assumed to share every spine authorization.
In September 2026, Enovis announced a binding offer to acquire eCential, with closing expected by year-end subject to approvals and process requirements. The reviewed primary announcements describe a proposed transaction; completion has not been established. Clément Vidal is identified as CEO in the company’s appointment announcement.
eCential’s Op.n navigation and robotic-guidance platform has matched 510(k) decisions, alongside earlier SURGIVISIO records. Imaging, navigation, robotic assistance and partner-specific configurations must be distinguished; an earlier platform authorization is not automatic clearance for every new application. [18][1][2][3][10][11][13][14][20]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [22][23]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Open platform with selected U.S. spine navigation and robotic-guidance authorizations. [18][1][2]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial spine platform, partner-specific applications and proposed ownership change distinguished. No completed-acquisition claim. [18][1][2][3]
Proposed transaction expected by year-end 2026; closing not established by reviewed sources. [3]
FDA cleared Spine Navigation and Robotic Guidance under K261113. [2]
Accessed 10/29/2026