Genesys Spine wins FDA nod for AIS-C stand-alone spine device

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

The Genesys Spine system is a non-screw-based, zero-profile, direct-anterior stand-alone inter body system for the cervical spine. It was designed for ease of use for surgeons during every step of procedures.

“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,” said Dr. Matthew Philips, a board-certified neurosurgeon and director of the Brain and Spine Center at SouthCoast Health in Massachusetts, in a press release.

AIS-C Stand-Alone System features a direct anterior approach for a smaller, mid-line incision and non-screw-based fixation. It also has a quick, simple, non-impacting anchor insertion that doesn’t require an awl or drill and a zero-step locking mechanism. The locking mechanism has a feature that gives visual confirmation of engagement, but still allows for anchor removal when needed. The system is able to be easily revised or removed. Using removal instruments allows the locking mechanism to be defeated so the anchor can be removed without drilling.

“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,” Landon Gilkey, senior principal design engineer at Genesys Spine, said.

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