MiRus, LLC · Class II · Cleared Mar 18, 2026
| K-number | K253444 |
| Device name | EUROPA Posterior Cervical Fusion Navigated Instruments |
| Applicant | MiRus, LLC |
| Product code | OLO |
| Device class | Class II |
| Decision date | Mar 18, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The EUROPA™ Posterior Cervical Fusion Navigated Instruments are non-sterile, reusable surgical instruments designed for preparation and placement of EUROPA™ Posterior Cervical Fusion screws during spinal surgery. They work with the Medtronic StealthStation® stereotactic navigation system to help surgeons precisely locate anatomical structures in open or minimally invasive cervical fusion procedures.
The instruments have the same intended use, indications for use, and technological characteristics as the predicate systems, including identical design features, geometries, sizes, and materials. They are manufactured from Stainless Steel per ASTM F899 and are intended for manual operation with the Medtronic StealthStation® System.
ASTM F899 (stainless steel material specification). ISO 13485 design controls, nonconforming product, and corrective/preventative action requirements are referenced as applicable regulatory standards.
The EUROPA™ instruments are substantially equivalent because comparative dimensional analyses demonstrate equivalent critical geometry and array connection interfaces to the predicate devices. Engineering analyses confirm the subject devices have the same design features, geometries, sizes, materials, and performance characteristics as the cleared predicate instruments (Navigated CD HORIZON SCLERA Screwdrivers and Taps, and Navigated VERTEX SELECT Instruments).
View the full FDA submission: accessdata.fda.gov