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November 18, 2014

FDA grants 510(k) clearance for ZIP 51 interspinous fixation implant

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Aurora Spine's ZIP 51.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Aurora Spine’s ZIP 51.

It is the slimmest minimally invasive interspinous fixation implant for spinal fusion.

Developed as an alternative to pedicle screw fixation, ZIP 51 is designed for stabilisation and load sharing during the TI-S1 thoracolumbar fusion procedures.

The product is also intended to be an adjunct to interbody fusion, specifically to treat degenerative disc disease, spondylolisthesis, trauma and/or tumour.

Aurora Spine president Trent Northcutt said: "The new ZIP 51 represents our fifth FDA clearance in 11 months and maintains our position at the forefront, introducing advanced, innovative, minimally disruptive spine surgery technologies.

"Developed as an alternative to pedicle screw fixation, ZIP 51 is designed for stabilisation and load sharing during the TI-S1 thoracolumbar fusion procedures."

"This addition to our product portfolio serves spine surgeons performing our screw-less minimally invasive procedure that prefer a slimmer profile and flared lower spikes.

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"The success of our screw-less spine procedure is a testament to our laser focus on disruptive technology and our commitment to simplifying the complex."

According to the company, the product’s ZIP ONE-STEP locking mechanism reduces the use of a set screw.

ZIP 51 is designed in various sizes to accommodate variations in patient anatomy and each implant features a large barrel designed for ZIP Graft or other bone material.

Aurora Spine’s products are pre-packaged sterile, in order to provide the best products possible for both surgeons and patients.

The company is focused on bringing new solutions to the spinal implant market through a series of new minimally invasive, regenerative spinal implant technologies.

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