FDA clears Genesys Spine's AIS-C Stand-Alone System: 4 things to know

MIS

Genesys Spine received FDA clearance for its AIS-C Stand-Alone System.

Here are five things to know:

1. The system is a direct anterior approach to the cervical spine with a non-screw based fixation.

2. Surgeons do not need an awl or drill for anchor insertion; instead, the system includes non-impacting anchor insertion.

3. Genesys Spine designed the AIS-C Stand-Alone System with a zero-step locking mechanism that provides visual confirmation of engagement as well as allows for anchor removal.

4. Genesys Spine was founded in 2009 as a privately held company focused on medical implants.

"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," said Matthew Philips, MD, a director of the Brain and Spine Center at SouthCoast Health in Dartmouth, Mass. "This advantageous technique has made this my implant of choice for ACDFs."

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