While the options for surgical musculoskeletal repair continue to expand, a growing number of surgeons worldwide choose bone and soft tissue allografts as a safe, effective and convenient surgical option. Allografts bearing the SteriGraft™ label fulfill the discriminating surgeon’s desire to extend extraordinary patient care. Our superior level of allograft processing begins with rigorous Donor Screening and meticulous Donor Recovery Procedures, Certified Laboratory Testing, validated Tissue Cleansing, Sterile Packaging, and a meticulous Quality Assurance & Documentation system that ranks second to none.
These combine to form the proprietary, GraftShield™ allograft processing system, designed to set an entirely new standard in allograft sterilization. This system offers scientifically validated tissue sterilization (validated to SAL 10-6 in accordance with ISO 11137-2 Method 1) which virtually eliminates the risk of bacterial disease transmission.
To learn more about the various certifications of Gencure® Allografts and Texas Human Biologics, please click here.
To download a PDF file of our catalog pages which discuss our GraftShield™ human tissue processing systems, please click here.
A meticulous donor screening system has been developed to assure that only uniform, high quality tissues will be recovered and processed.
In accordance with FDA regulations and AATB Standards, donor tissues are tested by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and carefully analyzed using the latest technology in order to confirm that the donor is free from the following infectious diseases:
The Graftshield™ process makes improvements at multiple steps in the tissue processing system. Our processing partner, Texas Human Biologics utilizes a state of the art processing facility which makes the following steps possible.
SteriGraft™ Allograft Tissues from Gencure® Allografts are sterilized in their final packaging to ensure the highest patient safety. Our packaging processes ensure allografts arrive in the surgery in the best possible condition to facilitate a successful transplantation.
To comply with the standards set out by the American Association of Tissue Banks (AATB) and the U.S. Food and Drug Administration’s (FDA), Good Tissue Practices, Gencure® Allografts, its processing partner (THB), and the various donor processing organizations we work with all are subjected to an extensive quality process.