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.
“We have discovered that 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. 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,” CEO Kurt Jacobus said in prepared remarks.