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MedShape receives 510(k) clearance for femoral soft tissue fastener
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MedShape Inc. received 510(k) clearance from the FDA for the ExoShape Femoral Soft Tissue Fastener for soft tissue graft fixation on the femoral side of the knee joint during ACL reconstruction surgery.
The only femoral fixation device fabricated completely out of PEEK Altera polymer, the ExoShape Femoral Soft Tissue Fastener offers dual locking modes in cancellous bone and at aperture for complete anatomic ACL reconstruction. According to a company press release, the device is equipped with features that accommodate the femoral anatomy and loading conditions, including a Tendon Loop for shuttling the soft tissue graft into the bone tunnel, which allows for at least 20 mm of graft to be placed inside the tunnel. The ExoShape Femoral fastener also has locking modes that work in congruence to provide secure fixation.
“Orthopedic surgeons require speed, simplicity and performance in their devices. Using our shape memory technology, we have designed an ACL fastener that can be implanted quickly and easily, while still offering excellent fixation,” Kurt Jacobus, chief executive officer of MedShape, stated. “Our shape memory technology also allows our implants to expand and compress the graft without inducing damage or rotating the graft. The addition of ExoShape Femoral now allows us to provide these benefits to both sides of an ACL reconstruction.”