Medos International SARL · Class II · Cleared Mar 27, 2026
| K-number | K260240 |
| Device name | SYMPHONY Navigation Ready Instruments |
| Applicant | Medos International SARL |
| Product code | OLO |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The SYMPHONY Navigation Ready Instruments are reusable surgical instruments designed to assist surgeons in locating anatomical structures during spinal procedures, particularly for placement of SYMPHONY OCT screws in cervical and thoracic polyaxial screw procedures. These instruments work with compatible navigation systems including VELYS SPINE Navigation, Brainlab Navigation System, and other systems to enable image-guided stereotactic surgery.
The device is manufactured from stainless steel and silicone rubber and maintains the same design and performance characteristics as predicate devices. The primary difference is expanded compatibility with an additional navigation system—the VELYS SPINE Navigation—achieved through existing VELYS Spine Instrument Arrays, without introducing new technological design changes.
Performance evaluations included fulfillment of navigation system instrument accuracy requirements, CAD model evaluation, simulated use evaluation, biocompatibility verification per ISO 10993-1:2018, and sterilization validation per ISO 17664-1:2021.
The SYMPHONY Navigation Ready Instruments are substantially equivalent because their indications for use, technological characteristics, design, materials, and performance are consistent with predicate devices. The addition of VELYS SPINE Navigation compatibility does not raise new safety or effectiveness questions, as it uses existing instrument arrays and applies recognized consensus standards and design controls.
View the full FDA submission: accessdata.fda.gov