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ALLUMIN8 was granted FDA 510(k) clearance to market the A8 INTEGR8 Porous Pedicle Screw System, offering what the company claims to be the first 5.5mm diameter pedicle screw produced through additive manufacturing.
The A8 INTEGR8 System represents the foundation of what ALLUMIN8 calls Therapeutic Hardware, a platform of next-generation orthopedic and spine implants designed to integrate advanced surface architecture and precision engineering with therapeutic delivery to treat nearly 300 disease states with bone contributing to spinal fusion failures.
The company’s approach leverages additive manufacturing to enable Gaussian topography features designed to support osseointegration and future compatibility with localized biologic delivery concepts under research.
Key engineering features include:
- Cultiv8 Lattice: Proprietary Gaussian lattice topography, designed by CTO Matthew Shomper, reflective of the unique pattern of vertebral bone, and is designed to promote mechanical interlock and surface area for bone integration. The topography is integrated throughout the length of the screw shank.
- A8 Circul8 Adapter (not FDA cleared for sale in the U.S.): Optional modular interface enabling intraoperative access for surgeon-directed injections, bone marrow draw, and/or cell delivery.
- Screw Thread In-growth: a patent-pending design feature with topography on the actual screw threads for purchase and ingrowth within pedicle bone.
Results of mechanical evaluations demonstrated high durability and resistance to fatigue at critical transition zones.
International distribution plans are already underway in the US, India, Dubai, Australia, Taiwan, and Japan.
“This clearance marks a pivotal milestone for our team and the dawn of a new era uniting spine technology with therapeutic innovation,” said Alyssa Huffman, Founder & CEO of ALLUMIN8. “It embodies the power of persistence and purpose; merging advanced engineering with a deep understanding of bone biology, biomechanical failure, and the real-world needs of patients and surgeons. We’re proud to begin shaping the next evolution of spinal fixation where hardware not only supports, but heals.”
Source: ALLUMIN8
