FDA 510(k) Recap: First Clearances in the Trauma Segment .
The article recaps recent U.S. FDA 510(k) clearances in the trauma device segment, focusing on two companies receiving their first approvals. BlueOcean Global secured clearance for its Excelsior external fixation system(K253291), a next-generation circular fixator that supports bone reconstruction and soft tissue management in complex cases such as trauma, infection, Charcot reconstruction, and chronic non-healing wounds, guided by a procedural framework called FASTR (Fixator Assisted Soft Tissue Repair). Toetal Solutions received clearance for its ZipToe Hammertoe Fusion System (K253325), a pre-loaded intramedullary implant kit designed to enable consistent fixation and streamlined surgical workflow for proximal interphalangeal joint arthrodesis in hammertoe procedures. Both clearances mark these companies’ initial entries into the trauma device market.
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