Spinal Devices Made using Additive Manufacturing Get FDA Green Light
3D-printed medical implants aren’t just sci-fi anymore – they’re the real deal. Two companies, Nvision Biomedical Technologies and Invibio Biomaterial Solutions, teamed up to create the first-ever 3D-printed PEEK interbody system for spinal fusions. Their new devices, designed for cervical and anterior lumbar interbody fusion (ALIF), are made with PEEK-OPTIMA™ and recently got the thumbs-up from the FDA. That means they’re now cleared for clinical use and ready to hit operating rooms.
PEEK (short for polyether ether ketone) is a durable thermoplastic that’s become a favorite for medical implants. Why? It can handle sterilization, is biocompatible, and stands up to heat, chemicals, and wear. PEEK also mimics the qualities of bone, helping tissues regenerate and encouraging faster fusion with surrounding bone. PEEK-OPTIMA has already been used in over 15 million implants, and it gives surgeons clear imaging to track the healing process.
The ALIF devices by Nvision and Invibio feature a mix of solid and porous structures. Dr. John Devine from Invibio explains the magic behind that: “The combination of solid and highly intricate porous PEEK-OPTIMA structures within the Nvision system allows for potential bone ingrowth to achieve fixation while maintaining the inherent benefits of PEEK-OPTIMA for imaging and bone-like modulus.”
How They Pulled It Off
To build these next-gen spinal devices, the companies used BOND3D’s cutting-edge tech. BOND3D’s manufacturing process ensures parts are strong in all directions and completely free of voids. This level of precision gives Nvision and Invibio the freedom to design complex devices that traditional manufacturing couldn’t match.
Dr. Devine shared why 3D printing is such a game-changer: “The proprietary BOND3D advanced manufacturing process used in this device is available through Invibio to allow device companies to realize their innovative designs. Being able to access this process is a breakthrough for device companies because it allows much greater design freedom that would not otherwise be possible with conventional manufacturing methods.”
Better Tools, Better Outcomes
Spine and orthopedic surgeon Dr. Steven Lee is excited about what these new implants mean for his patients. “These new interbody devices,” he said, “will allow me to further improve the quality of care and surgical outcomes that I can provide to my patients.”
He also pointed out that the elasticity of PEEK-OPTIMA helps prevent subsidence, meaning the implant is less likely to sink into the bone. Its radiolucent properties make it easy for surgeons to confirm whether the fusion is progressing properly. Dr. Lee added, “The benefit of a printed porous structure that mimics native bone allows for bone growth into the device itself – thereby enhancing the construct stability.”
Meet the Makers
Nvision Biomedical Technologies, based in San Antonio, Texas, specializes in medical devices and implants. Invibio Biomaterial Solutions, located in Lancashire, UK, provides high-performance biomaterials to medical device makers. Together, they’ve made a leap forward in spinal care, bringing advanced technology to the operating table.
It’s safe to say that with this new FDA-approved system, the future of spinal fusion is looking brighter – and more 3D-printed – than ever.
