Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

The Spectrum Spine Cervical and Lumbar Cage Systems are intervertebral fusion devices made of titanium alloy for anterior cervical or lumbar interbody fusion in skeletally mature patients with disc degeneration or instability. The devices restore intervertebral height and enable spinal fusion, featuring a proprietary nano-roughened surface (BioBraille) designed to improve bone fixation.

Both devices are composed of titanium alloy (Ti-6Al-4V ELI) per ASTM F136, offered in multiple footprints with varying heights and lordotic angles, available in smooth and rough finishes, and incorporate nanoscale surface features (10⁻⁹ meter level) created through surface alteration. The lumbar device includes multiple footprint options while the cervical device includes five specific footprints; both contain large graft windows and are gamma-sterilized.

ASTM F136 (titanium alloy specification). The submission references FDA's Guidance for Industry on Nanotechnology and employs imaging to demonstrate nanoscale surface features and in vitro studies showing increased Type I Collagen and Bone Sialoprotein expression in murine bone marrow stromal cells.

The subject devices have identical intended use (interbody fusion in skeletally mature patients), identical materials (titanium alloy Ti-6Al-4V ELI), identical sterilization method (gamma irradiation), and identical principle of operation as predicate devices. The only material difference is the addition of nano-roughened surface features, which are demonstrated to have biological activity consistent with improved bone fixation, making the devices as safe and effective as or better than predicate devices.