San Antonio-based medical device & implant manufacturing company Nvision Biomedical Technologies & Invibio Biomaterial Solutions™ from the UK received FDA clearance for their 3D-printed porous PEEK interbody system.
The 3D-printed PEEK interbody system was made from the high-performance polymer PEEK-OPTIMA™ – developed by Invibio – using proprietary Bond3D Additive Manufacturing tech.
The system comprises Cervical & Anterior Lumbar Interbody Fusion (ALIF) spine devices with extensive porous elements that can enhance multi-directional bone ingrowth & device fixation.
PEEK-OPTIMA™ is an element widely used in more than 15 million implants. Their mechanical features are closer to actual bone structures & extensive imaging capability than titanium implants allowing surgeons to monitor fusion progression.
Brian Kieser, Nvision’s CEO, said “Our partnership with Invibio on this project showcases our commitment to pushing the boundaries of medical device innovation. This latest FDA clearance builds on a history of successful co-development between Nvision and Invibio, particularly in spine and foot-and-ankle devices. We are thrilled to introduce the 3D-printed PEEK Cervical and ALIF lines, available in various footprints and lordotic angles & incorporating the same porous design features focused on promoting bone ingrowth.”
They have undergone performance testing earlier to file a new master file (MAF) with the FDA to assist their process.
“The proprietary BOND3D advanced manufacturing process used in this device is available through Invibio to allow device companies to realize their innovative designs. Accessing this process is a win for device companies because it allows much greater design freedom that would not otherwise be possible with conventional manufacturing methods. 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,” explains John Devine, MD of Invibio.
Author: Nagarjun M
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