Material Information

Regenafil^® and Regenaform^® allograft paste products are single donor allograft products that were shown in a human clinical study to induce bone formation. Each lot of product is tested using the athymic nude rat assay to verify osteoinductive potential after sterilization. Regenafil and Regenaform are processed by RTI Biologics, Inc. (RTI) and distributed by Exactech.

Tissue Processing

RTI’s innovations continuously raise the bar of science and safety for biologics: RTI was the first company to offer grafts designed to maximize each gift of donation and invent fully validated sterilization processes that include viral inactivation steps.

As a tissue processor and medical device manufacturer, RTI maintains a Quality Management System in compliance with the following federal and state licensure/regulations and voluntary standards:
    •    FDA Current Good Tissue Practices, 21 CFR Part 1271
    •    FDA Current Good Manufacturing Practices, 21 CFR Part 820
    •    State of Florida Statutes (other state licenses as applicable)
    •    AATB Standards for Tissue Banking
    •    ISO 13485, Medical Devices Quality Management Systems

RTI is registered with the U.S. Food and Drug Administration (FDA), which conducts periodic inspections. Quality inspections also are performed by applicable state regulatory agencies, as well as accreditation and certification organizations such as the American Association of Tissue Banks (AATB) and notified bodies for ISO certification.

RTI’s Biomedical Laboratory holds the following registrations, certifications or licenses:
    •    FDA registration
    •    CLIA Certificate of Compliance (Federal)
    •    State of Florida statutes (other state licenses as applicable)

Processing - Sterilization

RTI-processed bone pastes are sterilized through the demineralization process. This process has been validated to achieve viral inactivation, and combined with terminal sterilization, allows RTI to provide sterile DBM paste products.

“The demineralization process inactivated infectious retrovirus in infected cortical bone, thereby preventing disease transmission.”- Journal of Bone and Joint Surgery (February 2003)

The demineralization process is validated to inactivate relevant and model viruses:

• Human Immunodeficiency Virus (HIV)
• HCV Model (BVDV)
• Parvovirus (PPV)
• Herpes Virus Model (PrV)

Final safety assurance step:

Following processing, final packages are validated* to achieve 10-6 sterility level. Low-dose gamma sterilization did not significantly impact the OI score result in an in vivo rat assay.¹

Resources

• In vivo white paper
• Testing summary
  

References
1.  Data on file at Exactech

*All references to "validated" sterilization processes indicate that the validation meets or exceeds requirements for product sterilization, i.e. a SAL of 10-6 per AAMI and ISO Standards.