Acuity Surgical Units LLC, an Irving, Texas primarily based medical machine producer, has obtained FDA 510(okay) clearance (K243386) for its Ventris Interbody Fusion System, a sophisticated spinal implant machine manufactured utilizing AddUp’s FormUp 350 Laser Powder Mattress Fusion (LPBF) system.
Designed to reinforce surgical outcomes and streamline scientific workflows, the Ventris system delivers new implant heights, enhanced anatomical compatibility through lordosis choices, and elevated floor space for improved osteointegration. These efficiency positive factors are unlocked by the design freedom inherent in LPBF expertise, providing producers the flexibility to reimagine implant geometry with out compromising regulatory compliance.
The 510(okay) clearance from the US Meals and Drug Administration confirms the Ventris system is considerably equal to beforehand cleared predicate units and meets all needed security and effectiveness requirements.
A significant differentiator on this clearance was Acuity’s transition to AddUp’s FormUp 350 platform, confirmed by way of rigorous mechanical and biocompatibility testing. The platform’s strong course of management and repeatable half high quality cut back manufacturing dangers, speed up regulatory timelines, and future-proof machine portfolios in opposition to tightening trade requirements.
“This clearance represents a big validation of our expertise,” stated Nick Estock, Deputy CEO of AddUp. “We’re proud to help Acuity Surgical in bringing superior, FDA-cleared spinal implants to market utilizing the FormUp 350 platform. It’s a robust instance of how additive manufacturing is shaping the way forward for medical innovation.”
The FormUp 350 provides high-resolution half manufacturing, strong course of management, and a novel modular structure that allows protected and environment friendly powder administration. These options empower medical producers to push the boundaries of machine innovation whereas sustaining compliance with strict trade requirements.