Spineart and eCential Robotics proudly announce the 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the Spineart PERLA® TL application (PERLA® App) for use with the new eCential Robotics Op.nTM robotic navigation platform.
This clearance marks a significant milestone in advancing robotic-assisted spine surgery and demonstrating new ways to innovate by combining Spineart’s and eCential Robotics’ expertise. The newly approved PERLA® App, which further integrates the Spineart PERLA® TL Open and MIS screw systems with the eCential Op.nTM platform, offers a Spineart navigation-specific interface and dedicated Spineart navigated instruments, aiming to enhance surgical precision and procedural workflow. Additionally, by expanding the range of 3D C-arms compatible with the system, Spineart and eCential underscore their ability to provide cutting-edge solutions while optimizing available resources at medical facilities through modular solutions.
“We are excited to announce the 510(k) clearance for our first PERLA® App on the eCential Op.nTM platform. This underscores our commitment to delivering advanced procedural solutions to spine surgeons, ultimately benefiting their patients. Our partnership with eCential Robotics in surgical and robotic navigation has empowered us to pursue an innovative approach that enhances precision and workflow efficiency in the operating room while utilizing our implants and instruments for spine surgery.” said Jerome Trividic, CEO of Spineart.
“This 510(k) clearance shows our dedication to innovation and increasing the capabilities and modularity of our Op.nTM 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.”
Building on this successful collaboration, Spineart and eCential Robotics will continue to join forces to drive further innovation on the Op.nTM platform.