Acuity Surgical Units LLC, an Irving, Texas primarily based medical gadget producer, has obtained FDA 510(ok) clearance (K243386) for its Ventris Interbody Fusion System, a complicated spinal implant gadget manufactured utilizing AddUp’s FormUp 350 Laser Powder Mattress Fusion (LPBF) system.
Designed to boost 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 aspects 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(ok) clearance from the US Meals and Drug Administration confirms the Ventris system is considerably equal to beforehand cleared predicate units and meets all crucial security and effectiveness requirements.
A serious differentiator on this clearance was Acuity’s transition to AddUp’s FormUp 350 platform, confirmed by rigorous mechanical and biocompatibility testing. The platform’s strong course of management and repeatable half high quality scale back manufacturing dangers, speed up regulatory timelines, and future-proof gadget portfolios in opposition to tightening business requirements.
“This clearance represents a major validation of our expertise,” stated Nick Estock, Deputy CEO of AddUp. “We’re proud to assist Acuity Surgical in bringing superior, FDA-cleared spinal implants to market utilizing the FormUp 350 platform. It’s a strong instance of how additive manufacturing is shaping the way forward for medical innovation.”
The FormUp 350 gives 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 gadget innovation whereas sustaining compliance with strict business requirements.
