SpinePoint Receives FDA Clearance for Flex-Z Cervical Cage

SpinePoint was granted FDA 510(k) clearance to market the Flex-Z Cervical Cage.

The Flex-Z cage is designed to address the stiffness mismatch between conventional interbody implants and vertebral bone. Through a 3D-printed porous titanium architecture, and a patented Z shape to allow for cushioning, the Flex-Z is engineered to provide ultra-low stiffness approaching that of cancelous bone, while maintaining the structural integrity and durability required for spinal surgery.

The Flex-Z Cervical Cage is the first cleared product in a planned platform of eight interbody devices spanning cervical, lumbar, and lateral approaches. The platform’s underlying intellectual property is protected through 2043.

The Flex-Z is manufactured using 3D-printed porous titanium produced by Oaktree Additive, packaged by PCL, and sterilized by Steris via gamma irradiation.

“The Flex-Z is the answer — a cleared device, version nine of our design, built for the way spine surgery is actually practiced today: outpatient, ASC-based, and surgeon-driven.” — Lali Sekhon, founder of SpinePoint LLC.

Source: SpinePoint

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