Spectrum Spine Lumbar Cage System

The Spectrum Spine Lumbar Cage System is a titanium interbody fusion device designed for treating lumbar degenerative disc disease in skeletally mature patients at one or two contiguous spinal levels (L2–S1). It is used with supplemental fixation and bone graft to facilitate spinal fusion and restore disc height.

The device is manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, offered in multiple footprints with varying heights and lordotic angles in both smooth and roughened surface finishes. It includes a large graft window for bone graft placement and is accompanied by stainless steel surgical instruments for implantation.

Mechanical testing per ASTM F2077-22 (static and dynamic axial compression and compression shear), ASTM F2267-22 (subsidence), and testing for expulsion were performed.

The device has substantially similar indications for use, materials, geometry, and design to multiple predicate devices including the Medtronic Endoskeleton system. Performance testing demonstrates the subject device performs equivalent to or better than previously cleared predicates, and there are only insignificant differences between designs, establishing that no new safety or effectiveness questions are raised.