Information

Certification

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 Community Tissue Services (CTS). 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 CTS 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.

Safety 

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, and 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.

Quality

Our partners, AlloSource and CTS, 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 case structural damage to soft tissue. As the largest provider of fresh osteochondral grafts, we provide quality biologic solutions for surgeons and their patients.

JRF Ortho - W9
Form W-9—Request for Taxpayer Identification Number and Certification—is one of the most commonly used IRS forms.
AATB - AlloSource
AMERICAN ASSOCIATION OF TISSUE BANKS ACCREDITATION REQUIREMENTS
AATB - CTS
AMERICAN ASSOCIATION OF TISSUE BANKS ACCREDITATION REQUIREMENTS
JRF Ortho - FDA San Leandro, CA
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
JRF Ortho - FDA Centennial, CO
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
JRF Ortho - California (Centennial) Tissue Bank License
CALIFORNIA DEPARTMENT OF HEALTH AND MENTAL HYGIENE OFFICE OF HEALTH CARE QUALITY TISSUE BANK PERMIT
JRF Ortho - California Tissue Bank License
CALIFORNIA DEPARTMENT OF HEALTH AND MENTAL HYGIENE OFFICE OF HEALTH CARE QUALITY TISSUE BANK PERMIT
JRF Ortho - Delaware Tissue Bank License
DELAWARE DEPARTMENT OF HEALTH AND MENTAL HYGIENE OFFICE OF HEALTH CARE QUALITY TISSUE BANK PERMIT
JRF Ortho - Illinois Tissue Bank License
ILLINOIS DEPARTMENT OF HEALTH AND MENTAL HYGIENE OFFICE OF HEALTH CARE QUALITY TISSUE BANK PERMIT
JRF Ortho - Maryland Tissue Bank License
MARYLAND DEPARTMENT OF HEALTH AND MENTAL HYGIENE OFFICE OF HEALTH CARE QUALITY TISSUE BANK PERMIT
JRF Ortho - Oregon (San Leandro) Tissue Bank License
OREGON DEPARTMENT OF HEALTH AND MENTAL HYGIENE OFFICE OF HEALTH CARE QUALITY TISSUE BANK PERMIT
JRF Ortho - Oregon (Centennial) Tissue Bank License
OREGON DEPARTMENT OF HEALTH AND MENTAL HYGIENE OFFICE OF HEALTH CARE QUALITY TISSUE BANK PERMIT
JRF Ortho Package Insert
JRF ORTHO PACKAGE INSERT