Materials

Demineralized Bone Matrix (DBM) Human Allograft is produced from ground cortical bone.

Donor Selection

All donor tissue is recovered, processed and distributed according to standards established by the American Association of Tissue Banks.

Donor screening following the Tissue Banks International exclusion criteria is performed via donor physical inspection, interview with a person who knew the donor, review of available medical records, and a review of autopsy findings (when applicable). Individuals considered to be at high risk for AIDS or hepatitis as defined by the FDA and CDC are excluded from donorship. Using FDA licensed test kits in a CLIA certified lab, a serum sample from the donor has passed a hemodilution review and tested non-reactive for the following:

• Human immunodeficiency virus antibody (anti-HIV1 and 2)
• Human immunodeficiency virus (HIVp-24 and /or PCR) or (HIVp-24 and /or PCR and HIV 1 NAT) or (HIV 1 NAT)
• Hepatitis B surface antigen (HBsAg)
• Hepatitis B core antibody (HBcAb)
• Hepatitis C (anti-HCV) or (anti-HCV and HCV NAT)
• Human T-lymphotophic virus type I and II antibody (anti HTLV-I and II)
• Rapid plasma reagin (RPR) or serological tests for syphilis (STS)