The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Spineart's PERLA® TL application (PERLA® App) for use with eCential Robotics' Op.n™ robotic navigation platform, the companies announced on March 13, 2025. This regulatory milestone represents a significant advancement in robotic-assisted spine surgery technology.
The newly approved application further integrates Spineart's PERLA® TL Open and MIS screw systems with the eCential Op.n™ platform, providing spine surgeons with a Spineart navigation-specific interface and dedicated navigated instruments. The system aims to enhance surgical precision and improve procedural workflow in the operating room.
Jerome Trividic, CEO of Spineart, emphasized the significance of this development: "We are excited to announce the 510(k) clearance for our first PERLA® App on the eCential Op.n™ platform. This underscores our commitment to delivering advanced procedural solutions to spine surgeons, ultimately benefiting their patients."
The collaboration leverages the strengths of both companies—Spineart's expertise in spine surgery innovation and eCential Robotics' advanced robotic navigation technology. By combining these capabilities, the partnership has created a solution that enhances precision and workflow efficiency while utilizing Spineart's implants and instruments specifically designed for spine surgery.
Enhanced Modularity and Resource Optimization
A key advantage of the newly cleared system is its expanded compatibility with a range of 3D C-arms. This feature allows medical facilities to optimize their existing resources through modular solutions, potentially reducing the need for entirely new equipment investments while still accessing cutting-edge robotic navigation technology.
"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."
Technical Capabilities and Clinical Benefits
The PERLA® App is designed to work seamlessly with eCential's Op.n™ platform, which features an open ecosystem approach to surgical robotics. This platform is implant-agnostic, modular, and scalable, allowing for flexibility in surgical applications and future expansions.
For spine surgeons, the system offers enhanced visualization and navigation capabilities during complex procedures. The dedicated Spineart navigated instruments are specifically designed to work with the company's PERLA® TL Open and MIS screw systems, creating an integrated solution that may improve placement accuracy and potentially reduce procedure time.
Future Collaboration
Building on this successful regulatory achievement, Spineart and eCential Robotics have indicated they will continue their collaboration to drive further innovation on the Op.n™ platform. This ongoing partnership suggests potential future developments in robotic-assisted spine surgery technologies.
The spine surgery robotics market has seen significant growth in recent years, driven by increasing demand for minimally invasive procedures and technologies that enhance surgical precision. This FDA clearance positions both companies to compete effectively in this expanding market segment.
Company Backgrounds
Spineart is a global company focused on spine surgery innovation, known for its commitment to quality, innovation, and simplicity in spinal surgery solutions. The company offers a comprehensive portfolio of procedural solutions and digital technologies for spine surgery and was recognized with the "Prix de l'Economie Genevoise 2022" for its contributions to technological and scientific innovations.
eCential Robotics, founded by Stéphane Lavallée, is a French and US-based company specializing in surgical robotics. The company has developed its unique OPEN ecosystem platform with over 100 patents and seven trademarks. eCential's approach focuses on increasing robotic capabilities, decentralizing innovation through third-party development, and giving surgeons and hospitals control over their clinical, technological, and capital investment strategies.
