Acuity Surgical Gadgets LLC, an Irving, Texas primarily based medical system producer, has obtained FDA 510(okay) clearance (K243386) for its Ventris Interbody Fusion System, a sophisticated spinal implant system 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 by way of lordosis choices, and elevated floor space for improved osteointegration. These efficiency positive factors are unlocked by the design freedom inherent in LPBF know-how, 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 crucial security and effectiveness requirements.
A serious differentiator on this clearance was Acuity’s transition to AddUp’s FormUp 350 platform, confirmed by means of rigorous mechanical and biocompatibility testing. The platform’s sturdy course of management and repeatable half high quality scale back manufacturing dangers, speed up regulatory timelines, and future-proof system portfolios towards tightening business requirements.
“This clearance represents a big validation of our know-how,” 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 presents high-resolution half manufacturing, sturdy course of management, and a novel modular structure that permits secure and environment friendly powder administration. These options empower medical producers to push the boundaries of system innovation whereas sustaining compliance with strict business requirements.
