SpinePoint LLC has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the Flex-Z Cervical Cage, a product 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 cancellous bone, while maintaining the structural integrity and durability required for spinal surgery, according to the Reno, Nev.-based firm.

“Twenty years ago, I had an idea that the field was building implants that were fundamentally too stiff for the bone they sit against,” stated SpinePoint Founder Lali Sekhon, M.D., Ph.D., a practicing neurosurgeon who has completed more than 10,000 career surgeries. “The Flex-Z is the answer to that question—a cleared device, version nine of our design, built for the way spine surgery is actually practiced today: outpatient, ASC-based, and surgeon-driven.”

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 through a supply chain purpose-built for regulatory compliance and scale: 3D-printed porous titanium produced by Oaktree Additive (Tampa, Fla.), packaged by PCL (Kentwood, Mich.), and sterilized by Steris through gamma irradiation.

“The technology is real—and it addresses a problem that has been part of the conversation in spine surgery for a long time. I will wholeheartedly try it when available,” said Karthik Madhavan, M.D., assistant professor at Cooper University Health Care.

SpinePoint LLC’s Flex-Z platform addresses the biomechanical stiffness mismatch between conventional spinal implants and vertebral bone through 3D-printed porous titanium architecture, and a patented Z-shape design that cushions load transfer and achieves an elastic modulus approaching that of cancellous bone. The company is privately held.