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Home » Spineart, eCential Robotics earn FDA nod for robotic-assisted spine surgery application

Spineart, eCential Robotics earn FDA nod for robotic-assisted spine surgery application

March 13, 2025 By Sean Whooley

A marketing image of the robotic arm of the eCential Robotics surgical robotic robotic spine surgery system
The robotic arm of the eCential Robotics platform for spine surgery [Image courtesy of eCential Robotics]
Spineart and eCential Robotics today announced the receipt of FDA 510(k) clearance for the use of an application for robotic navigation.

The FDA cleared the Spineart Perla TL application for use with the new eCential Op.n robotic navigation platform. Both companies say the clearance marks a significant milestone in advancing robotic-assisted spine surgery

Spineart’s Perla app further integrates the Perla TL Open and MIS screw systems with the eCential Op.n platform. It offers a Spineart navigation-specific interface and dedicated Spineart navigated instruments. This aims to enhance surgical precision and procedural workflow. Additionally, the companies say the integration expands the range of 3D C-arms compatible with the system.

[For more on the wide world of surgical robotics, see our special report on the space.]

eCential and Spineart say they plan to continue to drive further innovation on the Op.n platform following this recent collaboration. Spineart CE Jerome Trividic said the clearance underscores the companies’ commitment to delivering advanced procedural solutions to spine surgeons.

“This 510(k) clearance shows our dedication to innovation and increasing the capabilities and modularity of our Op.n platform for surgical and robotic navigation,” said Clement Vidal, CEO of eCential Robotics. “By combining our partner Spineart’s spine systems with our expertise in advanced robotic navigation, we are bringing a transformative solution to the operating room, benefiting both surgeons and patients while optimizing cost for medical facilities.”

Filed Under: 510(k), Food & Drug Administration (FDA), Health Technology, Orthopedic Implants, Orthopedics, Regulatory/Compliance, Robotic-Assisted, Spine, Surgical, Surgical Robotics Tagged With: eCential, eCential Robotics, Spineart

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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