Eminent Spine’s 3D Titanium Anterior Lumbar Stand-Alone System Usage Report and Clinical Study
Eminent Spine received 510(k) approval of their 3D Titanium Anterior Lumbar Interbody Fusion Stand-Alone System in October of 2022. Since then, Eminent Spine has had a total of 40 3D Titanium ALIF Stand-Alone implants used in procedures in patients who were candidates for an Anterior Lumbar Interbody Fusion. The implants also come paired with screws that are self-tapping and self-drilling. Of the 120 screws used, all 120 were variable and ranged from 20-35 millimeters and 5.0-5.5 in diameter.
The 3D ALIF is comprised of various sizes and configurations to accommodate individual patient anatomy. The implant was designed with the following: a tapered nose and rounded edges which allows for ease of insertion, aggressive teeth to resist migration, lordosis for ease of insertion, self-distraction, and aggressive teeth for implant fixation. The implant profiles include heights ranging from 10-20mm, 5 different width x depth options, and lordosis of 12 degrees (custom lordosis of 0, 6, 18, 24, and 30 degrees are available upon request). The locking tab shows visible security of self-tapping, self-drilling screws. Surgeon’s feedback has been positive regarding the simplicity of the instrumentation and variety of footprints offered. There has been no reports of screw back-out, screw breakage, cage migration, cage fracture, or malfunction of the locking mechanism. This study of the Eminent Spine Cervical Stand-Alone has shown that the Eminent Spine 3D Titanium ALIF Stand-Alone is a device that can be safely implanted.
Eminent Spine’s 3D Titanium ALIF Stand-Alone System includes non-sterile implants with a wide range of implant profiles with both fixed and variable screw options. The 3D Titanium ALIF Stand-Alone is accompanied by Eminent Spine’s 3D Titanium Lumbar Interbody Fusion Systems PLIF and TLIF (also received FDA 510(K) clearance in May of 2023). Eminent Spine also has a completed ALIF prep set available per request.
“Keep it simple.”