BIOCOMPATIBILITY STUDIES OF NANO COMPOSITE PEKK VS PURE PEKK

Abstract

Biocompatibility has traditionally been concerned with implantable devices that have been intended to remain within an individual for a long duration, often for the lifetime of the patient, making the understanding of material-tissue interactions over extended time periods critically important for clinical success. This concept encompasses the biological performance of materials in the context of their intended application, considering not only the absence of harmful effects but also the ability of the material to perform its desired function without eliciting unacceptable local or systemic responses from the host organism. The term biocompatibility is used extensively within biomaterials science, appearing in countless research publications, regulatory documents, and clinical guidelines, but there still exists a great deal of uncertainty about what it actually means and about the underlying mechanisms that govern the interactions between synthetic materials and biological systems. This conceptual ambiguity arises from the complexity of biological responses, which can vary depending on the material composition, surface characteristics, implantation site, mechanical loading conditions, and individual patient factors, making it challenging to develop universal definitions or predictive models that apply across all situations. Contemporary understanding recognizes that biocompatibility is not an intrinsic property of a material itself but rather a context-dependent characteristic that emerges from the dynamic interplay between the material and the host environment, requiring comprehensive evaluation through both in vitro and in vivo testing strategies.