| K-number | K254148 |
| Device name | VERTICALE GPS Instruments |
| Applicant | Silony Medical GmbH |
| Product code | OLO |
| Device class | Class II |
| Decision date | Feb 19, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The VERTICALE GPS Instruments are non-sterile, reusable surgical instruments (awls, drills, taps, probes, burrs, and screwdrivers) made of medical-grade stainless steel. They are used with the Globus Excelsius GPS robotic navigation system to assist surgeons in precisely locating anatomical structures and placing VERTICALE pedicle screws during spinal surgery in skeletally mature patients through open or minimally invasive procedures.
The subject and predicate devices have nearly identical technological characteristics including device design and dimensions, indications for use, materials of manufacture, and principles of operation. The minor differences between them do not raise new safety or effectiveness issues.
ISO 17665-1:2016 for reprocessing and sterility validation; ISO 10993-1:2018 for biocompatibility assessment.
The VERTICALE GPS Instruments are substantially equivalent to the predicate Excelsius GPS device based on geometric comparison, functional assessment of mating arrays, and instrument verification showing equivalent critical geometry for function and positional accuracy. Engineering analysis and non-clinical testing demonstrate equivalent performance to the predicate device.
View the full FDA submission: accessdata.fda.gov