MedShape Inc., Atlanta, announces FDA 510(k) clearance for its shape-memory PEEK ExoShape Femoral Soft Tissue Fastener for soft tissue graft fixation on the femoral side of the knee joint during anterior cruciate ligament (ACL) reconstructive surgery. The use of MedShape’s proprietary shape memory PEEK Altera enables the fastener to be pre-compressed to a low profile for easy insertion, and then fully expanded for effective graft-to-tunnel compression and secure graft fixation
Set to launch this month, it is the only femoral fixation device fabricated completely out of PEEK Altera polymer and offers dual locking modes in cancellous bone and at aperture to achieve complete anatomic ACL reconstruction.
The implant is equipped with several features uniquely designed to accommodate the femoral anatomy and loading conditions. These design features include a Tendon Loop for shuttling the soft tissue graft into the bone tunnel, allowing for at least 20 mm of graft to be placed inside the tunnel. The ExoShape Femoral also has two locking modes that work in congruence to provide secure fixation:
1. Shape Memory Wings that deploy and lock into cancellous bone
2. Expandable Block Lock technology that provides uniform graft compression and aperture fixation,
Dr. John Uribe of the UHZ Sports Medicine Institute in Coral Gables, Fla. currently uses the tibial version for his ACL procedures and is earnestly awaiting the release of ExoShape Femoral. “The ExoShape Femoral is an unrivaled device with the use of shape memory PEEK to provide effective soft tissue graft compression and fixation as well as an easy insertion method. Applying compression is important with promoting graft to bone healing,” said Dr. Uribe. “I believe many surgeons will recognize the benefits of this system and adopt it for their ACL reconstruction procedures.”
