US FDA clears EOI’s FLXfit15 expandable cage

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Expanding Orthopedics FLXfit
Expanding Orthopedics’ FLXfit device

Expanding Orthopedics Incorporated (EOI) has received US Food and Drug Administration (FDA) 510(k) clearance for the FLXfit15. The device offers infinitely adjustable expansion, and lordosis correction of up to 4mm and 15 degrees.

The FLXfit15 is intended to expand the surgeon’s flexibility and capability with a family of products in different length options.

The product builds on the FLXfit expandable interbody system, a clinical study which was reported in October 2016.

The higher range expansion of the FLXfit15 is designed to restore lordosis angle up to 15 degrees. According to a press release, the 32mm length option will offer great flexibility in treating patients with smaller anatomies.

Largest-in-class MIS TLIF expandable cage

According to an earlier press release from the time of the product’s receipt of CE mark, this is the largest in-class transforaminal lumbar interbody fusion expandable cage in the minimally invasive spinal fusion market.

Dale Binke, EOI’s vice president of US Sales, notes that, “One of the major trends in fusion surgeries is progression towards minimally invasive surgery procedures, inpatient or outpatient.”

However, Dale explains, “There is an inherent challenge in inserting a large interbody cage that restores lumbar lordosis while controlling sagittal and coronal alignment.”

“The FLXfit,” he adds, “can be delivered through a minimally invasive window and [offers] a unique expansion mechanism that restores lordosis.”

The FLXfit15, he concludes, combines an articulating cage with optimal footprint. It “can be easily delivered and expanded in a controlled manner,” he says.

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