| K-number | K253545 |
| Device name | Vulcan Spinal System |
| Applicant | K2m, Inc. |
| Product code | NKB |
| Device class | Class II |
| Decision date | Feb 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
The Vulcan Spinal System is a posterior spinal fixation device composed of polyaxial pedicle screws, locking set screws, and rods. It is intended for non-cervical pedicle fixation as an adjunct to fusion in adult and pediatric patients with conditions such as degenerative disc disease, spondylolisthesis, trauma, stenosis, spinal curvatures, tumor, pseudarthrosis, and failed previous fusion.
The device is a top-loading, multiple-component, non-cervical spinal fixation system implanted from the posterior approach. Device comparisons show substantial equivalence to predicate devices based on intended use, indications for use, design, materials, sterilization method, performance characteristics, and operational principles.
Static Compression Bending (ASTM F1717-21), Dynamic Compression Bending (ASTM F1717-21), Axial grip testing (ASTM F1798-24), and Torsional grip (ASTM F1798-24).
The Vulcan Spinal System possesses the same intended use and technological characteristics as the predicate devices (Everest Spinal System, Xia 3 System, Olympic Posterior Spinal Fixation System, and Mesa Spinal System). Mechanical testing results demonstrate that the device is substantially equivalent to the predicate devices, and clinical testing was not required.
View the full FDA submission: accessdata.fda.gov