SpinePoint LLC announces U.S. FDA 510(k) clearance of the Flex-Z™ Cervical Cage (K252432) on March 25, 2026 — the first cleared product in an eight-device ultra low stiffness interbody platform protected by IP through 2043. Built from 3D-printed porous titanium, the Flex-Z™ is engineered to match cancellous bone stiffness in anterior cervical fusion
RENO, Nev., March 27, 2026 /PRNewswire-PRWeb/ -- SpinePoint LLC, a medical device company developing low stiffness cushioning spinal interbody cages through advanced additive manufacturing, announced that the Flex-Z™ Cervical Cage has received U.S. Food and Drug Administration (FDA) 510(k) clearance (K252432) on March 25, 2026.
The Flex-Z™ Cervical 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 cancellous 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.
"Twenty years ago, I had an idea that the field was building implants that were fundamentally too stiff for the bone they sit against," said Lali Sekhon, MD PhD MBA, founder of SpinePoint LLC. "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 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." — Karthik Madhavan, MD FAANS, Assistant Professor, Cooper University Health Care.
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, FL), packaged by PCL (Kentwood, MI), and sterilized by Steris via gamma irradiation.
About SpinePoint LLC
SpinePoint LLC is a Reno, Nevada-based medical device company founded by Lali Sekhon, MD PhD MBA, a practicing neurosurgeon with over 10,000 career surgeries. SpinePoint'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's IP is protected through 2043. SpinePoint is privately held.
Media Contact
Lali Sekhon, MD, PhD, MBA, SpinePoint LLC, 1 7758158097, [email protected], http://www.spinepointusa.com
SOURCE SpinePoint LLC
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