| K-number | K253331 |
| Device name | PressON Spinal Fixation System |
| Applicant | Nexus Spine |
| Product code | NKB |
| Device class | Class II |
| Decision date | Oct 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
The PressON Spinal Fixation System is a posterior pedicle screw system composed of titanium alloy (Ti-6Al-4V ELI) screws, couplers, and rods designed to immobilize and stabilize spinal segments in skeletally mature patients. It is used as an adjunct to fusion for treating thoracic, lumbar, and sacral spine instabilities or deformities including degenerative disc disease, spondylolisthesis, fracture, scoliosis, kyphosis, and failed previous fusion.
The subject device adds an extension coupler assembly to the existing PressON system. Components are made from Ti-6Al-4V ELI (ASTM F136) and use the same materials and technical characteristics as the predicate device, with the modification limited to the coupler assembly design.
ASTM F1717 Dynamic Compression Bending, ASTM F1798 Axial Load Gripping Capacity, ASTM F1798 Axial Torsion Gripping Capacity, and ASTM F1798 Flexion-Extension Gripping Capacity.
The subject device is substantially equivalent because its indications for use, materials (Ti-6Al-4V ELI), and technical characteristics are similar to the predicate device (PressON K223529). Performance testing demonstrates comparable mechanical behavior, and the extension coupler modification does not alter the fundamental function or safety profile of the system.
View the full FDA submission: accessdata.fda.gov