Acuity Surgical Gadgets LLC, an Irving, Texas primarily based medical gadget producer, has acquired 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 reinforce surgical outcomes and streamline medical 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 features 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(ok) clearance from the US Meals and Drug Administration confirms the Ventris system is considerably equal to beforehand cleared predicate gadgets and meets all obligatory security and effectiveness requirements.
A significant differentiator on this clearance was Acuity’s transition to AddUp’s FormUp 350 platform, confirmed by rigorous mechanical and biocompatibility testing. The platform’s sturdy course of management and repeatable half high quality cut back manufacturing dangers, speed up regulatory timelines, and future-proof gadget portfolios towards tightening business requirements.
“This clearance represents a major 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 gives high-resolution half manufacturing, sturdy course of management, and a singular modular structure that permits 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.
