LICENSES & CERTIFICATIONS

JRF Ortho is one of the largest providers of fresh osteochondral, fresh‐frozen meniscus, sterile tendons, and frozen segmental grafts in the country. Using peer‐reviewed literature for guidance, we have established donor criteria that maximize the availability of allografts while maintaining proper graft biomechanical integrity. For our collagen grafts, e.g. tibialis tendons and bone tendons, we distribute tissue primarily from donors 12 to 65 years of age. For meniscus and fresh osteochondral grafts we distribute tissue from donors 12 to 35 years of age. JRF Ortho is registered with the U.S. Food and Drug Administration (FDA) and maintains state licensure where appropriate. Allografts provided by JRF Ortho are processed and prepared by our partners, AlloSource and Solvita. Both organizations maintain CLIA-certified testing laboratories and process tissue in clean rooms designed with HEPA filtered and environmentally and microbiologically monitored air. Reagents, equipment, instruments, and packaging materials used in processing meet the same standards as those used in the operating room. AlloSource and Solvita are accredited by the AATB and registered with the FDA. Both organizations are committed to manufacturing and distributing tissue and tissue-based medical products in compliance with current FDA regulations 21 CFR Parts 820 and 1271 and other applicable standards.

Maximizing allograft safety while providing quality allografts for joint restoration is our primary goal. All tissue is processed by our partners who are accredited by the AATB and the Clinical Laboratory Improvement Amendments (CLIA) and who meet or exceed all FDA cGTP requirements. Bacterial contamination is significantly limited due to detailed donor, medical and social history rule out criteria, 14 day incubation destructive and fluid extraction testing, as well as aseptic environmental and processing techniques that meets or exceeds AATB and FDA‐cGTP requirements. JRF Ortho tissue meets or exceeds both FDA and AATB requirements for serologic screening. Allograft safety is of paramount importance and our rigorous screening and sterilization process, called Sterile R, enables us to provide the safest tendon allograft alternative possible for elective procedures. JRF Ortho has honored the Center for Disease Control’s (CDC) recommendation by using ultra low-dose, cold temperature irradiation on all collagen grafts, achieving a sterility assurance level (SAL) of 10‐6, the level defined as terminal sterilization.

Our partners, AlloSource and Solvita, produce quality allografts processed within current Good Tissue Practices (cGTP) as defined by the FDA and comply with all AATB guidelines regarding tissue recovery, processing and safety. Using ultra low-dose irradiation at cold temperatures on our collagen grafts has proven to reduce the debilitating effects of previous sterilizing methods by reducing free radicals that cause structural damage to soft tissue. As the largest provider of fresh osteochondral grafts, we provide quality biologic solutions for surgeons and their patients.