Ulrich Medical USA, Inc. · Class II · Cleared Jul 1, 2025
| K-number | K251719 |
| Device name | Momentum® Posterior Spinal Fixation System |
| Applicant | Ulrich Medical USA, Inc. |
| Product code | NKB |
| Device class | Class II |
| Decision date | Jul 1, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
The Momentum® Posterior Spinal Fixation System is a pedicle screw and rod system for spinal fixation and correction in the thoracolumbar and sacroiliac spine in skeletally mature patients. It is indicated for degenerative disc disease, spinal stenosis, spondylolisthesis, deformities, trauma, tumor, pseudoarthrosis, and failed fusion, and can be used with G21 V-Steady bone cement for advanced-stage tumor patients when fusion is not achievable.
The subject and predicate devices share identical or nearly identical indications for use, structure and function, size and styles, materials (titanium alloy Ti-6Al-4V ELI and cobalt chromium CoCr-28Mo), sterility, and manufacturing/biocompatibility requirements. This submission adds hooks, connectors, and monoaxial screws to previously cleared components.
ASTM F1717 Dynamic Compression Bending; ASTM F136 and ISO 5832-3 for titanium alloy; ASTM F1537 and ISO 5832-12 for cobalt chromium.
The worst-case configuration was previously shown substantially equivalent under K191932. The new components (hooks, connectors, monoaxial screws) introduce no new worst-case scenario and were evaluated under fatigue testing using ASTM F1717, demonstrating mechanical strength sufficient for intended use and equivalent to legally marketed predicates with identical technological characteristics.
View the full FDA submission: accessdata.fda.gov