Incomplete removal of donor cells and endogenous intracellular debris has the potential to elicit an acute inflammatory and/or immune response from the host and the possibility of rejection. The presence of donor cells has been implicated in host inflammatory reactions associated with other xenograft implants.1 Our products are effectively decellularized through a validated manufacturing process, ensuring the safety and biocompatibility of all our bioimplants.
Biocompatibility
As FDA-regulated medical devices, OrthADAPT® Bioimplant and Unite® Biomatrix were subjected to the required ISO (International Organization for Standardization) biocompatibility test panel. Results from independent testing confirm that our products meet or exceed these safety standards.
1 Valentin JE et al. Extracellular Matrix Bioscaffolds for Orthopaedic Applications: A Comparative Histologic Study. JBJSA 2006; 88(12):2673-2686.