| K-number | K253158 |
| Device name | VyBrate VBR System |
| Applicant | Vy Spine, LLC |
| Product code | MQP |
| Device class | Class II |
| Decision date | Jan 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
The VyBrate™ VBR System is a spinal vertebral body replacement device made of OXPEKK with tantalum markers. It is used in the thoracolumbar spine (T1-L5) and cervical spine (C3-C7) to replace collapsed, damaged, or unstable vertebral bodies due to tumor, trauma, or fracture. The device must be used with supplemental fixation systems and bone graft material as an adjunct to fusion.
The device has equivalent technological characteristics to predicate devices in design, intended use, material composition (OXPEKK with tantalum markers), and function. It does not contain software or electrical equipment and is available in multiple sizes for both cervical and lumbar applications.
Mechanical testing was performed following ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02 standards. Tests included static and dynamic axial compression, torsion, compressive shear, expulsion, and subsidence. Sterilization validations were also performed.
The VyBrate™ VBR System is substantially equivalent to the primary predicate Oxford Performance Materials SpineFab VBR (K142005) and secondary predicates because it shares the same material, design, sizes, indications for use, biocompatibility, and function. The subject device has identical technological characteristics to predicates that are already cleared for commercial distribution.
View the full FDA submission: accessdata.fda.gov