Introduction
On March 13, 2025, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to the PERLA® TL App from Spineart for use with the Op.n™ robotic navigation platform by eCential Robotics. This milestone solidifies the shift toward increasingly digital and connected operating rooms, where robotics and software-based surgical planning take center stage.What is the PERLA® App?
PERLA® TL App is a software module (“application”) that integrates Spineart’s PERLA® TL Open and MIS pedicle screws into the Op.n™ ecosystem. This provides the surgeon with:
- Spineart-specific navigation interface. Implants are automatically recognized and virtually positioned in the preoperative plan.
- Dedicated navigated instrumentation. Instrumentation is calibrated with the robot, enhancing precision and shortening the learning curve.
- Expanded 3D C-arm compatibility. The system supports multiple brands of 3D fluoroscopy, optimizing hospital resources.
The Op.n™ Platform: An Open Ecosystem
eCential Robotics presents its platform as an “OPEN” ecosystem powered by independent apps, similar to smartphones. Its key features include:
- All-in-one: 2D/3D imaging, navigation, and robotic arm in a single tower.
- Implant independence: Allows third parties to develop their own applications, avoiding dependence on a single brand.
- Modularity: Hospitals can add functions according to their needs and budget.
Clinical and Operational Benefits
| Dimension | Expected Impact |
|---|---|
| Precision | Robotic guidance reduces pedicle screw placement errors by up to 1–2 mm. |
| Safety | Reduced intraoperative radiation thanks to 3D navigation. |
| Efficiency | Optimized workflow: shorter setup time and capability for minimally invasive procedures. |
| Total Cost | The open architecture eliminates the obligation to purchase proprietary implants, fostering competition. |
“This clearance demonstrates our commitment to providing advanced solutions that benefit both surgeons and patients,” commented Jérôme Trividic, CEO of Spineart.
Market Context
Robot-assisted spinal surgery has grown at rates exceeding 20 % annually, driven by the pursuit of reproducible outcomes and fewer complications. Competitors such as Medtronic (Mazor™), Globus (Excelsius™), and Zimmer Biomet (Rosa™) dominate the market, but eCential Robotics’ open and agnostic approach aims to differentiate itself in an increasingly competitive environment.
About the Companies
- Spineart (Geneva, Switzerland) operates in over 60 markets and was recognized with the Prix de l’Économie Genevoise 2022 for its innovation.
- eCential Robotics (Grenoble, France – Dallas, USA) holds over 100 patents and has surpassed 2,500 surgeries recorded with its platform.
Implications for Our Patients
- More precise trajectories in complex spine surgeries.
- Minimally invasive procedures with reduced postoperative pain and faster discharge.
- Advanced surgical planning, resulting in safer and more efficient surgeries.
We will continue to closely monitor the evolution of the Op.n™ platform and the availability of the PERLA® App in the U.S. market.
Conclusion
The synergy between Spineart and eCential Robotics embodied in the PERLA® App represents a step forward in democratizing robotic spine surgery. Its modular and open approach has the potential to accelerate the adoption of robotic navigation in centers that, until now, were constrained by closed and expensive solutions.
Are you interested in learning how robotics can transform your treatment? Contact us at Complex Spine Institute to schedule a personalized evaluation.
Editorial credit: Article prepared by the Complex Spine Institute team based on public sources (GlobeNewswire, SPINEMarketGroup, eCential-Robotics, ORTHOWORLD).
