Spineart SA · Class II · Cleared Mar 7, 2025
| K-number | K242890 |
| Device name | SPINEART Navigation Instrument System |
| Applicant | Spineart SA |
| Product code | OLO |
| Device class | Class II |
| Decision date | Mar 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The SPINEART Navigation Instrument System is a set of reusable surgical instruments designed to assist surgeons in precisely locating anatomical structures during thoracolumbar spinal surgery for placement of SPINEART PERLA TL screws. It works with the eCential Op.n PERLA TL Navigation System using intraoperative 3D images and is indicated for patients requiring spinal screw placement where stereotactic surgery is appropriate.
The subject device adds a SPINEART eCential Navigation Adapter and Navigation Bs Checking Tip to enable compatibility with the eCential Op.n Navigation System, whereas the predicate (K210472) was designed for use with the Medtronic Stealthstation Navigation System. The adapter and checking tip do not alter the core design features or technological characteristics of the navigation instruments themselves.
ASTM F2554 verification was conducted on the eCential Navigation Adapter in a worst-case scenario with the eCential Op.n Perla TL Nav system. Accuracy verification was performed according to a protocol defined by eCential to confirm compatibility and performance.
The addition of the eCential Navigation Adapter enables the existing SPINEART Navigation Reusable Instruments to work with a different navigation system without raising accuracy issues. Performance testing demonstrated that accuracy with the eCential system is equivalent to the acceptance criteria established for the predicate device with Medtronic Stealthstation. The intended use, design features, and safety/effectiveness profile remain unchanged—only the compatible navigation platform has been expanded.
View the full FDA submission: accessdata.fda.gov