Acuity receives FDA 510(k) clearance for Ventris spinal implant additively manufactured using AddUp FormUp 350
May 8, 2025
AddUp, headquartered in Cébazat, France, has announced that its partner, Acuity Surgical Devices LLC, Irving, Texas, has received FDA 510(k) clearance (K243386) for its Ventris Interbody Fusion System, an advanced spinal implant device manufactured using the FormUp 350 Laser Beam Powder Bed Fusion (PBF-LB) Additive Manufacturing machine following the company’s in-house adoption of the machine in 2024.
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Designed to enhance surgical outcomes and streamline clinical workflows, the Ventris system is said to deliver improved anatomical compatibility via lordosis options, and increased surface area for improved osteointegration. These performance gains are attributed to the design freedom enabled by PBF-LB Additive Manufacturing technology, which offers manufacturers the ability to reimagine implant geometry without impacting regulatory compliance.
The 510(k) clearance from the US Food and Drug Administration (FDA) confirms that the Ventris system is substantially equivalent to previously cleared predicate devices and meets all necessary safety and effectiveness standards. This clearance is noted as a major milestone for AddUp and Acuity Surgical, showcasing the suitability of Additive Manufacturing – and AddUp’s FormUp 350 – for critical medical device applications.
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“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.”
