Acuity Surgical Devices LLC, an Irving, Texas based medical device manufacturer, has received FDA 510(k) clearance (K243386) for its Ventris Interbody Fusion System, an advanced spinal implant device manufactured using AddUp’s FormUp 350 Laser Powder Bed Fusion (LPBF) system.
Designed to enhance surgical outcomes and streamline clinical workflows, the Ventris system delivers new implant heights, enhanced anatomical compatibility via lordosis options, and increased surface area for improved osteointegration. These performance gains are unlocked by the design freedom inherent in LPBF technology, offering manufacturers the ability to reimagine implant geometry without compromising regulatory compliance.
The 510(k) clearance from the US Food and Drug Administration confirms the Ventris system is substantially equivalent to previously cleared predicate devices and meets all necessary safety and effectiveness standards.
A major differentiator in this clearance was Acuity’s transition to AddUp’s FormUp 350 platform, proven through rigorous mechanical and biocompatibility testing. The platform’s robust process control and repeatable part quality reduce production risks, accelerate regulatory timelines, and future-proof device portfolios against tightening industry standards.
“This clearance represents a significant validation of our technology,” said Nick Estock, Deputy CEO of AddUp. “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.”
The FormUp 350 offers high-resolution part production, robust process control, and a unique modular architecture that enables safe and efficient powder management. These features empower medical manufacturers to push the boundaries of device innovation while maintaining compliance with strict industry standards.
