IsoTis® Pure Strips are 100% human allograft, composed of demineralized bone matrix and donor-matched musculoskeletal tissue. The implants are designed specifically for use in lumbar fusion procedures.
Verified Osteoinductive Potential - Each lot is tested for osteoinductive potential1 following terminal sterilization. The demineralized Bone Matrix (DBM) is sterilized through the Cancelle® SP DBM sterilization process, which is designed to preserve naturally occurring proteins and physical structure of the tissue. Each lot is tested for osteoinductive potential following terminal sterilization.
1DBM or representative finished implant is either assayed in vivo in the modified athymic nude rat for bone formation or in vitro for endogenous BMP-2 as a surrogate test marker for osteoinductive potential. Because the combination of various proteins is responsible for osteoinductive potential, DBM when assayed in vitro, is also screened for the presence of BMP-7. Findings from an in vitro assay or animal model are not necessarily predictive of human clinical results.
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