| K-number | K253432 |
| Device name | DiversiVy Facet Screw System |
| Applicant | Vy Spine, LLC |
| Product code | MRW |
| Device class | Class U |
| Decision date | Mar 19, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The DiversiVy™ Facet Screw System is a spinal implant device made of titanium alloy screws that insert through the facets of adjacent vertebral bodies to stabilize the spine and aid fusion. It is indicated for posterior surgical treatment at single or multiple levels from L1 to S1 for conditions including spondylolisthesis, spondylolysis, pseudoarthrosis, failed previous fusions, and degenerative disc disease.
The device is composed of titanium alloy screws conforming to ASTM F-136. It is equivalent to predicate devices in terms of material composition, intended use, levels of attachment, and size range.
ASTM F-136 (titanium alloy material standard). Mechanical performance was demonstrated through engineering analysis of bending strength and axial pullout strength compared to predicate devices.
The DiversiVy™ Facet Screw System is substantially equivalent to the Spinal USA Facet Screw System (K130863) predicate device based on equivalent technological characteristics including design, intended use, material composition, and function, with comparable mechanical performance demonstrated through engineering analysis.
View the full FDA submission: accessdata.fda.gov