Plano, TX, March 15, 2024 — 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 102 3D Titanium ALIF Stand-Alone implants used in procedures in patients who were candidates for an Anterior Lumbar Interbody Fusion. Of these 102 implants, 62 have been used since January 2024, demonstrating a substantial increase in demand. The implants also come paired with screws that are self-tapping and self-drilling. Of the 273 screws used, all 273 were variable and ranged from 20-35 millimeters and 5.0, 5.5, and 6.0 millimeters in diameter (diameter of 4.5mm is available in May 2024).
The Eminent Spine 3D Titanium ALIF Stand-Alone implant profiles include heights ranging from 10mm – 20mm, 3 different width x depth options (32mm x 21mm, 35mm x 25mm, and 38mm x 26mm), and lordosis of 12-degrees. There will also be a lordosis of 6° and 18° available in May 2024. In addition, there are No Teeth, Flat Series ALIF implant options available with 12-degree lordosis, 12mm – 18mm range for the height, and profiles of 35mm x 25mm and 38mm x 26mm.
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 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 have been no reports of screw back-out, screw breakage, cage migration, cage fracture, or malfunction of the locking mechanism. This study 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.