OptiMesh Multiplanar Expandable Interbody Fusion System

The OptiMesh Multiplanar Expandable Interbody Fusion System is a non-rigid spinal implant device designed to contain FDA-cleared bone void filler within the intervertebral body space. It is indicated as an adjunct to fusion surgery for degenerative disc disease with up to Grade I spondylolisthesis at one lumbar level (L2–S1) in skeletally mature patients who have completed six months of conservative care.

The subject device is identical in design, geometry, and intended function to the predicate device, with the addition of a hydroxyapatite (HA) nano-scale surface treatment (20–40 nanometers) applied to the mesh component. This HA surface treatment is materially identical to that used on the reference device.

Benchtop functional and mechanical characterization testing; benchtop performance adhesion testing; and benchtop ASTM performance testing were conducted to confirm function and performance compared to the predicate device.

The OptiMesh HAnano implants are substantially equivalent to the predicate because they maintain identical indications for use, geometric design, design function, and core technology, with only the addition of a nano-scale HA surface treatment that does not raise questions of safety or effectiveness. Non-clinical testing demonstrated that the HA-treated implants function and perform as intended compared to the predicate.