Our manufacture prepares donated tissue for transplantation through extensive testing and screening, and validated sterilization processes. Each donor is subject to a thorough eligibility evaluation, including a donor risk assessment interview with the family, medical records review, infectious disease testing, autopsy report review (if performed), and physical assessment. Based on all screening and testing results, donor tissue is determined to be suitable for transplant by our Medical Director. Only donors that meet Pinnacle’s rigorous criteria are released to processing.

Our controlled tissue processing environment and procedures are designed to ensure allograft tissue quality and safety. Pinnacle’s tissue sterilization process allows bone and soft tissue to maintain biomechanical integrity while achieving a sterility assurance level (SAL) of 10-6.