Xenograft Interference Screw

The device has been cleared by the U.S. Food and Drug Administration (FDA).

The Sterling interference screw has a long-term absorption rate, which ensures secure graft fixation throughout the healing process, and pullout strength is comparable to metal interference screws. Developed by Regeneration Technologies, Inc. (RTI, Alachua, FL, USA; www.rtix.com), the implant offers the benefits of RTI's patented BioCleanse tissue sterilization process. This enables delivery of xenograft implants that are sterile and have improved biocompatibility and preserved structural integrity.

"We have the opportunity to capitalize on our competencies to develop new implants and to safely process and sterilize xenograft tissue to supplement the unmet demand for biological solutions in surgery,” observed Brian K. Hutchison, chairman of RTI.

In 2002, the company sponsored an animal study of the effects of BioCleanse on xenograft tissue. The results showed that the BioCleanse treatment process renders bovine xenograft essentially equivalent to an allograft interference screw. RTI holds the patents on BioCleanse, which the company notes is the only proven tissue sterilization process validated to eliminate viruses, bacteria, fungi, and spores from tissue without affecting the structural or biomechanical integrity of the tissue. To date, RTI has distributed more than 600,000 allograft implants sterilized with the BioCleanse process, with zero incidence of infection.




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