Genesys Spine announces FDA clearance of AIS-C Stand-Alone System

Reviewed by James Ives, M.Psych. (Editor)Sep 11 2018

Genesys Spine is pleased to announce the FDA clearance of our latest product line, the AIS-C Stand-Alone System.

The AIS-C Stand-Alone system is a first of its kind, non-screw based, zero-profile, direct-anterior stand-alone interbody system for the cervical spine. It was designed to provide the greatest ease of use to the surgeon at every step of the procedure.

Advantages of the AIS-C Stand-Alone System include:

• Direct anterior approach – Allows for a smaller, mid-line incision.
• Non-screw-based fixation.
• Quick, simple, non-impacting anchor insertion – Does not need an awl or drill.
• Zero-step locking mechanism – Contains a locking feature that provides visual confirmation of engagement, but allows for anchor removal when desired.
• Easily revised or removed – Use of the removal instruments allows the locking mechanism to be defeated so the anchor can be extracted. No drilling is required.

Dr. Matthew Philips, board-certified neurosurgeon and Director of the Brain and Spine Center at SouthCoast Health in Massachusetts says, "The ease of application of the AIS-C Stand-Alone will reduce both my surgical times and the morbidity associated with plate and screw constructs. This advantageous technique has made this my implant of choice for ACDFs."

"The most significant aspect of the AIS-C design is its simplicity to implant. From a surgeon's perspective, there's only one extra step compared to a standard cervical fusion. Once everything is loaded, they simply squeeze the trigger of the inserter and detach from the implant." -J. Landon Gilkey, Senior Principal Design Engineer, Genesys Spine.

"The AIS-C Stand-Alone system works great from insertion to removal and I think it will remain one of Genesys' flagship products for years to come." -Benjamin Keller, Product Development Engineer, Genesys Spine.

Source: www.genesysspine.com