LITTLETON, Mass., Feb. 9 /PRNewswire/ -- Scandius BioMedical, Inc. announced today that its TriTis Tibial Fixation System has been granted 510(k) market clearance by the U.S. Food and Drug Administration (FDA) and has been used successfully in Anterior Cruciate Ligament (ACL) reconstruction, the single largest sports-related orthopedic joint injury. The new TriTis Tibial Fixation System's unique design provides strength in three ways: a Cleat for tissue compression in the tunnel, an off axis Fixation Screw to anchor the device and a Fixation Washer to capture graft limbs preventing graft slippage.
In early clinical use, the TriTis product has produced excellent clinical outcomes. According to Russell F. Warren, M.D., Hospital for Special Surgery, New York, NY, "The TriTis device provides improved tibial fixation with a locking device that will prevent implant motion and provide increased pull out strength. It is an excellent addition to tibial fixation for ACL reconstruction."
TriTis was developed to address the problem of fixation strength in the tibia where bone quality is softer, and stronger fixation is needed to hold a soft tissue graft in place. As a result the TriTis tibial fixation implant has been designed to provide a stronger and stiffer construct. When used in conjunction with the Stratis(TM) ST Femoral Fixation, the company is able to provide orthopedic surgeons with a complete solution for reconstruction of the ACL.
Paul Re, MD, Chief of Orthopedics at Emerson Hospital, Concord, MA and co- inventor of the TriTis system commented, "I have been very impressed with the clinical application of the TriTis, both in its ease of use and early clinical outcomes. In using the TriTis in conjunction with the Stratis, a stronger, stiffer construct is achieved than with other systems. The locking mechanisms of both devices are quite unique and complement each other, providing rigid, reliable fixation in soft tissue ACL reconstruction."
"FDA clearance of the TriTis tibial fixation technology marks another major milestone for our company. Current tibial fixation products often force surgeons to make a choice between intra-tunnel compression to achieve aperture fixation or cortical fixation to achieve strength. We believe that TriTis will offer both, providing surgeons with the optimal clinical outcome they desire," said Mark A. Johanson, Founder, President and CEO of Scandius.
About Scandius BioMedical, Inc.
Scandius BioMedical, Inc. is a privately held medical device company that designs, manufactures and markets products for the orthopedic sports medicine market. The company is focused on accelerating innovative solutions for minimally invasive orthopedic sports medicine procedures. Scandius maintains a strong R&D pipeline focused on procedure specific products that treat a variety of sports-related injuries, with future developments addressing the areas of arthroscopic shoulder surgery, articular cartilage, and meniscal repair. For more information please visit us at http://www.scandius.com.
Scandius is a registered trademark of Scandius BioMedical, Inc. Stratis is a trademark of Scandius BioMedical, Inc. TriTis is a trademark of Scandius BioMedical, Inc.
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Jennifer A. Silverman
Director of Marketing
Scandius BioMedical, Inc.