AddUp Inc., is proud to announce that its strategic partner, 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 the 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 U.S. Food and Drug Administration confirms the Ventris system is substantially equivalent to previously cleared predicate devices and meets all necessary safety and effectiveness standards. This clearance marks a major milestone for AddUp and Acuity Surgical, showcasing the precision and reliability of additive manufacturing for critical medical device applications.
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 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.”
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.
About Acuity Surgical
Acuity Surgical is a leading OEM in the medical device industry, specializing in comprehensive spinal surgery solutions. Established in 2013, the company is recognized for its commitment to innovation, quality, and customer satisfaction and is currently one of the Inc. 5000 Fastest-Growing Private Companies in America.
Acuity Surgical offers spine surgeons a comprehensive range of lumbar, cervical, and biologic solutions, designed to support bone healing, growth and repair. Located in Irving, Texas, Acuity Surgical is dedicated to advancing spinal surgery through high-quality, state-of-the-art implant systems and premier human tissue allograft solutions. Surgeons and patients can count on Acuity’s unwavering commitment to world class customer support. To learn more, visit: www.acuitysurgical.com.
