Osteomni, Inc. · Class II · Cleared Feb 24, 2026
| K-number | K254247 |
| Device name | OSTEOMNI SPINAL FIXATION SYSTEM |
| Applicant | Osteomni, Inc. |
| Product code | NKB |
| Device class | Class II |
| Decision date | Feb 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
The Osteomni Spinal Fixation System is a posterior spinal fixation system for the noncervical spine, consisting of polyaxial pedicle screws, monoaxial pedicle screws, spondylolisthesis screws, rods, connectors, hooks, and eyescrews. It is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients with conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, and pseudoarthrosis, as well as for pediatric pedicle screw fixation in posterior approaches.
There are no differences between the Osteomni Spinal Fixation System and the predicate device in indications for use, materials, operating principle, design/geometry, dimensions, material composition, or sterility. All components are supplied non-sterile, single use, and fabricated from titanium alloy (Ti6Al4V-ELI) conforming to ASTM F136.
ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), ASTM F1798 (Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies), ASTM F543 (Test Methods for Metallic Medical Bone Screws), and tulip-dissociation testing for interconnection strength evaluation.
The subject system is substantially equivalent to the Effortmed Spinal Fixation System (predicate K243946) because it has identical indications for use, materials, design, dimensions, operating principles, and sterility characteristics. Non-clinical testing demonstrated equivalent mechanical properties and performance under axial gripping, torque, flexion-extension, and interconnection strength testing.
View the full FDA submission: accessdata.fda.gov