MedShape wins 510(k) clearance for femoral fixation device

MedShape lands 510(k) clearance from the FDA for its ExoShape femoral soft tissue fastener for knee ligament repairs. MedShape said it won 510(k) clearance from the FDA for its ExoShape femoral soft tissue fastener, a shape memory polymer device used in knee reconstruction procedures. The Atlanta-based medical device company touts the ExoShape implant, for anterior cruciate ligament reconstruction surgeries, as "the only femoral fixation device fabricated completely out of PEEK Altera polymer," according to a press release. News Well, 510(k), Orthopedics, Regulatory/Compliance, Surgicalread more
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) MedShape Inc. Source Type: news