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MedShape obtains FDA 510(k) approval for ExoShape femoral soft tissue fastener

MedShape, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ExoShape femoral soft tissue fastener for use in soft tissue graft fixation on the femoral side of the knee joint during anterior cruciate ligament (ACL) reconstructive surgery.

The ExoShape femoral soft tissue fasteneris is made out of MedShape’s proprietary shape memory PEEK Altera polymer. The system offers dual locking modes in cancellous bone and at aperture to achieve complete anatomic ACL reconstruction.

MedShape claims that ExoShape is the only all PEEK device that offers non-rotational aperture soft tissue graft fixation on both the femoral and tibial sides to achieve complete anatomic ACL reconstruction.

ExoShape complements the tibial version, which was launched by MedShape in 2011. The implant includes several features that are designed to accommodate the femoral anatomy and loading conditions.

The implant features a tendon loop for shuttling the soft tissue graft into the bone tunnel, allowing for at least 20mm of graft to be placed inside the tunnel.

To provide secure fixation, the implant features two locking modes that work in congruence. These locking modes include shape memory wings which deploy and lock into cancellous bone, and expandable block lock technology that provides uniform graft compression and aperture fixation.

MedShape CEO Kurt Jacobus noted the company has 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," Jacobus added.

"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."

MedShape will launch the ExoShape femoral soft tissue fastener in February 2014. The implant is available in sizes 8-11mm and 21mm in length.

It will come pre-loaded on a delivery system with a flexible rod that enables simple tendon shuttling and easy navigation across the joint for both transtibial and anteromedial approaches. The flexible rod and non-rotational deployment mechanism facilitates non-line of sight delivery along a curved path.