DZ-Tabone Intervertebral Body Fusion Device

The DZ-Tabone Intervertebral Body Fusion Device is a tantalum metallic implant used to fuse one or two adjacent vertebral segments in the cervical (C2-T1) or lumbar (L2-S1) spine. It has a trabecular porous structure with a central bone graft window to facilitate bone ingrowth and maintain intervertebral space height in patients with degenerative disc disease, vertebral slippage, or instability who have failed conservative treatment.

The device is manufactured entirely from tantalum metal with convex upper and lower surfaces, a block structure, and a trabecular porous design with a central bone graft window. It is available in two variants (cervical CIF-PTA and lumbar LIF-PTA) and is sterilized by radiation. The technological characteristics are identical to the predicate devices in material composition, intended mechanism of action, and design principle.

ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), ASTM F2267 (Load-Induced Subsidence Testing), ISO 10993-1:2018 (Biocompatibility), ISO 11137 (Sterilization by Radiation), and limulus amebocyte lysate (LAL) testing for bacterial endotoxin (≤20 EU/device).

The DZ-Tabone device is substantially equivalent because it shares the same intended use (spinal fusion for degenerative disc disease), the same tantalum material composition, the same trabecular porous structure with bone graft window design, and comparable mechanical performance to predicate devices. Non-clinical testing demonstrated equivalent mechanical properties per ASTM standards, acceptable biocompatibility, and appropriate sterilization, with no material, design, or functional differences that would affect safety or effectiveness.