FortiVy™ OsteoVy™ Lumbar IBF

The FortiVy™ OsteoVy™ Lumbar IBF System is an intervertebral body fusion device surgically implanted between vertebral bodies to treat degenerative disc disease with up to Grade 1 spondylolisthesis. It is available in multiple anatomical shapes and sizes, designed for use with autogenous bone graft and supplemental spinal fixation, for one or two contiguous levels from L2 to S1 in skeletally mature patients who have completed six months of non-operative treatment.

The device is additively manufactured from Titanium 6Al-4V ELI (ASTM F3001-14) with a unique internal lattice structure mimicking cancellous bone. A variant includes a 20–40 nanoscale surface topography treatment in addition to macro-/micro-scale topography. The device contains no software or electrical components and is available in cylindrical, rectangular, elliptical, and hemi-cylindrical configurations.

ASTM F2077 (axial compression and compressive shear mechanical testing under static and dynamic loading) and ASTM F2267 (subsidence testing).

The FortiVy™ OsteoVy™ Lumbar IBF System is equivalent to its predicate devices (LumiVy™ Lumbar IBF, UniVy™ OsteoVy™ Cervical IBF, Reliance Lumbar IBF, and Nexxt Spine Matrixx) in intended use, material composition, design intent, and function. Although it uses additive manufacturing and incorporates a cancellous bone-mimicking lattice structure from secondary predicates, these are technological refinements that do not alter the fundamental design, intended use, or clinical function; nonclinical mechanical testing demonstrates equivalent or superior safety and performance.