Product DescriptionOssiGraft™ is a cryopreserved, viable bone matrix allograft containing cells in their native bone niche. OssiGraft™ is available in a variety of sizes and is intended for the repair, replacement, and reconstruction of musculoskeletal defects of the spine, pelvis, or extremities.
OssiGraft™ is a minimally manipulated HCT/P regulated by the FDA under section 361 of the Public Health Service Act and 21 CFR Part 1271 and does not require premarket authorization. Ossium Health complies with Good Tissue Practices and is an FDA-registered Tissue Establishment.
CharacterizationOssiGraft™ contains a minimum of 700,000 total viable cells/cc, confirmed via post-thaw testing. Of these, a minimum of 150,000 cells/cc are bone-forming (osteoprogenitor) cells. Outgrowth and trilineage differentiation have been performed as a surrogate test to prove the tissue is viable. Non-immunogenicity has been confirmed by Mixed Lymphocyte Reaction assay.
- Source: Vertebral bodies of organ donors
- Age: Median donor age of 37
- Tissue recovery time: ≤ 8 hours
- Time to process: ≤ 60 hours
- Time to cryopreservation: ≤ 70 hours
- Storage: cryopreserved at <-140°C
- Sterility: USP <71> sterility tested
- Donor screening: All donors are screened according to FDA requirements for HCT/Ps (human cells, tissues, and cellular and tissue-based products)