The US medical technology company Acuity Surgical Devices has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new Ventris Interbody Fusion System. The spinal implant is manufactured using Laser Powder Bed Fusion (LPBF) technology on AddUp‘s FormUp 350 system. The approval confirms the equivalence of the product with already approved comparator implants and fulfills all safety and efficacy requirements.
The implant system was developed with the aim of improving surgical results and optimizing clinical procedures. Thanks to the design freedom of additive manufacturing, new geometries could be implemented, such as variable lordosis angles for anatomical adaptation and an enlarged surface to promote osteointegration. Such features are difficult or impossible to realize with conventional manufacturing methods without compromising regulatory requirements.
The approval is based on comprehensive mechanical and biocompatibility tests that affect both the implant itself and the additive manufacturing process. AddUp points to the high process stability and reproducibility of the FormUp 350 platform. Thanks to its modular system architecture and efficient powder management, the system offers the necessary control to consistently manufacture medical devices on an industrial scale, according to the manufacturer.
“This clearance represents a significant validation of our technology,” said Nick Estock, Deputy CEO of AddUp Inc. “We’re proud to support Acuity Surgical in bringing advanced, FDA-cleared spinal implants to market using the FormUp 350 platform. It’s a powerful example of how additive manufacturing is shaping the future of medical innovation.”
Especially against the backdrop of stricter industry regulations, LPBF technology can help to shorten development cycles while still ensuring a high level of safety and quality. The approval of the Ventris system thus marks a concrete step towards the routine use of additive manufacturing in medical technology.
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