Plano, TX, November 16, 2023 – Eminent Spine received 510(k) approval of their Cervical Stand-Alone System on November 5, 2021. Since May of 2022, Eminent Spine has had a total of 163 Cervical Stand-Alone implants used in procedures in patients who were candidates for Anterior Cervical Discectomy and Fusion. Of these Cervical Stand-Alone implants, 85 have been reported to be 3D titanium and 78 reported to be PEEK. The implants also come paired with cervical screws that are self-tapping and self-drilling. Of the 379 screws used, 362 were variable and 17 were fixed.
The cervical implant was designed with the following: a tapered nose which allows for ease of insertion, lordosis for ease of insertion, self-distraction, and aggressive teeth for implant fixation. Micro-teeth on the top faces of the implant prevent micro-migration and micro-motion. The locking tab shows visible security of self-tapping, self-drilling screws. There is one universal driver for screws and locking tab for ease in the OR.
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 of the Eminent Spine Cervical Stand-Alone has shown that the Eminent Spine Cervical Stand-Alone is a device that can be safely implanted.
Eminent Spine’s Cervical Stand-Alone System includes non-sterile implants with a wide range of implant profiles with both fixed and variable screw options. The Cervical Stand-Alone System is accompanied by Eminent Spine’s extensive cervical IBFD cages (which are available in PEEK, Machined Titanium and 3D Printed Titanium) and the Anterior Cervical Plate System.
Eminent Spine continues to “Keep it Simple.”
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