Aurora Gets FDA Clearance for New Spine System Sizes

California devicemaker Aurora Spine has received FDA 510(k) clearances for new 35 mm and 40 mm sizes of its sterile-packed Zip Ultra minimally invasive interspinous fusion system and 35 mm, 40 mm and 45 mm sizes of Zip MIS.

Zip MIS is used to immobilize and stabilize spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. Among its features are nonarticulating bone anchors, a one-step locking mechanism without a set screw and a graft space for biologic material.

The new sizes will be available at the end of the third quarter of this year, Aurora says.

Zip Ultra was developed as a minimally invasive alternative to pedicle screw fixation, according to the company. It is designed to stabilize during T1-S1 lumbar fusion procedures that treat degenerative disc diseases, spondylolisthesis, spinal tumors and traumatic injuries. Like its counterpart, Zip Ultra has a one-step locking mechanism without the set screw and can accommodate different patient anatomies.

Both Zip and Zip Ultra are CE-marked. — Lena Freund

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