How is this different from PERLA's earlier Op.n clearance?

Spineart and eCential Robotics previously cleared PERLA for use with the Op.n platform's navigation-only function. This new 510(k) extends that same PERLA TL application to Op.n's robotic-assisted workflows, so surgeons can use integrated navigation and active robotics together rather than navigation alone.

What procedures does the clearance cover?

Both open and minimally invasive (MIS) pedicle screw placement using the PERLA TL Open and MIS systems, positioned by the companies as supporting implant-placement accuracy and workflow efficiency in either approach.

Devices

FDA Clears Spineart’s Robotic Spine Screw App

Q: What did FDA clear on 26 August 2026?

A 510(k) clearance for Spineart's PERLA TL application — covering PERLA TL Open and MIS pedicle screw systems — for use with eCential Robotics' Op.n Navigation and Robotic-Assisted Platform in robotic-assisted spine procedures. The companies announced the clearance jointly from Geneva.

Q: Who are Spineart and eCential Robotics?

Spineart is a Geneva-based spine implant manufacturer; eCential Robotics develops the Op.n intraoperative imaging, navigation, and robotic-assistance platform for spine surgery. The companies did not publish the specific FDA 510(k) submission number in their joint announcement.

The 510(k) extends Spineart's PERLA TL pedicle-screw planning app — already cleared for eCential Robotics' Op.n navigation platform — to robotic-assisted workflows, letting surgeons pair navigation and active robotics in the same open or minimally invasive procedure.

Connor GriggsEditor·August 26, 2026·4 min read

FDA cleared Spineart's PERLA TL pedicle-screw application for robotic-assisted use with eCential Robotics' Op.n platform on 26 August 2026, extending a planning app the companies had already cleared for Op.n's navigation-only mode into active robotic workflows for both open and minimally invasive spine surgery.

From navigation to robotics, one app at a time

Spine navigation and robotic-assisted spine surgery are related but separately cleared capabilities: a navigation system tracks instrument position against a registered anatomical image, while a robotic-assist system physically guides or constrains instrument placement. Spineart's PERLA planning application was first cleared for use with eCential's Op.n platform in its navigation-only configuration, letting surgeons plan pedicle screw trajectories and see them tracked on Op.n's imaging and navigation display. This clearance is the step that lets the same PERLA TL planning data drive Op.n's robotic-assisted function directly, rather than navigation and robotics running as separate, non-integrated systems in the same operating room.

What the companies say it changes for surgeons

Laurent Nodé-Langlois, Spineart's Chief Technology Officer, said in the companies' announcement that the clearance introduces "a truly collaborative robotic platform that brings simplicity, precision, and active robotics capabilities together to help redefine the surgical experience for spine surgeons and their patients." The companies frame the combined navigation-plus-robotics workflow as supporting implant-placement accuracy and workflow efficiency across both open and MIS pedicle screw procedures, rather than requiring surgeons to choose between the two approaches or switch platforms mid-case.

What is not yet public

As with many device 510(k) announcements, the companies' joint release did not include the FDA submission number, a predicate device comparison, or a performance-testing summary; FDA's public 510(k) database typically posts new clearance records days to weeks after a company announcement. Regulatory News will update this story if FDA's database entry surfaces additional detail once indexed.

Frequently asked questions

What did FDA clear on 26 August 2026?

A 510(k) for Spineart's PERLA TL application, covering PERLA TL Open and MIS pedicle screw systems, for robotic-assisted use with eCential Robotics' Op.n Navigation and Robotic-Assisted Platform.

How is this different from the earlier PERLA-Op.n clearance?

The earlier clearance covered Op.n's navigation-only function. This one extends the same PERLA TL app to Op.n's robotic-assisted workflows, combining navigation and active robotics.

What procedures does it cover?

Open and minimally invasive (MIS) pedicle screw placement using the PERLA TL Open and MIS systems.

Who are Spineart and eCential Robotics?

Spineart is a Geneva-based spine implant maker; eCential Robotics builds the Op.n imaging, navigation, and robotic-assistance platform. The companies have not published the FDA 510(k) number for this clearance.

Sources & further reading

Spineart and eCential Robotics, “Spineart and eCential Robotics receive FDA 510(k) clearance for the PERLA® TL application for use with eCential® Op.n® navigation system for robotic procedures”, press release, 26 August 2026. prnewswire.com
Same announcement, as posted on Spineart's newsroom. spineart.com
Ortho Spine News, “Spineart and eCential Robotics receive FDA 510(k) clearance for the PERLA® TL application for use with eCential® Op.n® navigation system for robotic procedures”, 26 August 2026. orthospinenews.com

Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.

The Index