RTI's Xenograft Implant Gets FDA 510(k)

The STERLING Interference Screw ST from Florida-based implant maker Regeneration Technologies (RTI) has received 510(k) clearance from the FDA for use in an arthroscopic or open ACL and/or PCL reconstruction.

RTI's STERLING Interference Screw offers the benefits of the company's patented BioCleanse Tissue Sterilization Process, which enables delivery of xenograft implants -- defined as a tissue graft between two different species -- that are sterile with improved biocompatibility and preserved structural integrity.

The xenograft screw has a long-term absorption rate, ensuring secure graft fixation throughout the healing process. Also, its pullout strength is comparable to metal interference screws. The STERLING Interference Screw ST should be available for distribution in late 2005.