Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))

The Mobarn 80:20 Lumbar Interbody Fusion System is a family of titanium spinal fusion cages designed for lumbar interbody fusion via posterior (PLIF), transforaminal (TLIF), lateral (DLIF), or anterior (ALIF) approaches. The devices provide structural support to facilitate bone fusion in skeletally mature patients with degenerative disc disease at one or two contiguous lumbar levels (L2-S1) who have failed conservative treatment and may have up to Grade 1 spondylolisthesis.

The devices are additively manufactured from Ti6Al4V-ELI titanium with an 80% open architecture surrounded by a 20% titanium frame to accommodate autograft and allograft bone. They come in multiple footprints, heights, and lordotic angles. The design, materials, manufacturing process (additive manufacturing), and comparable instruments match the predicate devices, and mechanical performance is demonstrated via ASTM F2077 and F2267 testing.

ASTM F2077 (static and dynamic axial compression, static and dynamic compressive shear), ASTM F2267 (subsidence), and expulsion testing. Testing was conducted per FDA's May 3, 2004 Guidance for Industry and FDA Staff – Spinal System 510(k)s and the June 12, 2007 Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.

The subject device matches the primary predicate (Zyston Strut, K171495) and reference predicate (4Web Medical PLIF/TLIF/OLIF STS, K143258) in intended use, operating principle, open architecture design, Ti6Al4V material composition, additive manufacturing process, and demonstrated mechanical performance via standard ASTM testing. The similarities in design, materials, manufacturing, and comparative mechanical testing establish that the Mobarn 80:20 will perform as safely and effectively as legally marketed predicate devices for the same indications.