Spineart and eCential Robotics have gained U.S. Food and Drug Administration (FDA) 510(k) clearance for the Spineart PERLA TL application (PERLA App) for use on eCential’s new Op.n robotic navigation platform.

The newly approved PERLA App further integrates the Spineart PERLA TL Open and MIS screw systems with the eCential Op.n platform, offering navigation-specific interface and dedicated Spineart navigated instruments. This aims to boost surgical precision and procedural workflow.

Expanding the range of 3D C-arms compatible with the system underscores the duo’s ability to offer 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,” said Spineart CEO Jerome Trividic. “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.”

The two companies said they will continue to join forces to drive innovation on the Op.n platform. They began their partnership in January 2023.

“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.”

In September 2024, eCential made two new strategic hires to its leadership team.