This article provides a summary of biocompatibility or biological response of metals, ceramics, and polymers used in medical implant, along with their clinical issues. The polymers include ultrahigh-molecular-weight polyethylene, nonresorbable polymer, and resorbable polymers.

This article outlines some of the selection criteria for choosing an implant material for biomedical devices in orthopedic, dental, soft-tissue, and cardiovascular applications. It details the development of implants based on materials, such as metallic implants, ceramic implants, and polymeric implants. The article discusses the specific problems associated with implant manufacturing processes and the consequent compromises in properties of functionally graded implants. It describes the manufacturing of the functionally-graded hip implant by using the LENS process. It reviews the four different types of tissue responses to the biomaterial. The article discusses the testing of implant failure, such as in vitro and in vivo assessment of tissue compatibility.

Porous coatings are used in the field of joint replacement, particularly in cementless total hip/knee arthroplasty. This article reviews the offerings and biomaterial properties in orthopedic surgery for the contemporary class of highly porous metals. It describes the traditional porous metal/coating having an open-cell structure, high porosity, and a microsctructure resembling that of cancellous bone. The traditional porous metal/coating includes fiber-metal mesh, cobalt-chromium (CoCr) beads, cancellous-structured titanium, and plasma spray. The article discusses other porous metal/coating due to the limitations of traditional porous metals for numerous open-cell-structured metals, such as titanium-base foams and trabecular metal.

The biocompatibility of a material relates to its immunological response, toxicity profile, and ability to integrate with surrounding tissue without undesirable local or systemic effects on a patient. This article underscores the transformation of the medical device design ecosystem engaged as an integral part of the device ecosystem. It discusses the various applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes the four major categories of biomaterials, such as metals, polymers, glass and ceramics, and composites. A discussion on natural materials, nanomaterials, and stem cells is also provided. The article concludes with information on examples of biomaterials applications, including endovascular devices, knee implants, and neurostimulation.

This article commences with a description of the prosthetic devices and implants used for internal fixation. It describes the complications related to implants and provides a list of major standards for orthopedic implant materials. The article illustrates the body environment and its interactions with implants. The considerations for designing internal fixation devices are also described. The article analyzes failed internal fixation devices by explaining the failures of implants and prosthetic devices due to implant deficiencies, mechanical or biomechanical conditions, and degradation. Finally, the article discusses the fatigue properties of implant materials and the fractures of total hip joint prostheses.

This article focuses on ceramics, glasses, glass-ceramics, and their derivatives, that is, inorganic-organic hybrids, in the forms of solid or porous bodies, oxide layers/coatings, and particles with sizes ranging from nanometers to micrometers, or even millimetres. These include inert crystalline ceramics, porous ceramics, calcium phosphate ceramics, and bioactive glasses. The article discusses the compositions of ceramics and carbon-base implant materials, and examines their differences in processing and structure. It describes the chemical and microstructural basis for their differences in physical properties, and relates properties and hard-tissue response to particular clinical applications. The article provides information on glass or glass-ceramic particles for cancer treatments.

This article addresses the biologic aspects of implant debris both locally and systemically. It discusses the particulate debris, such as stainless steel, cobalt alloy, and titanium alloy, and soluble debris obtained due to wear from all orthopedic implants. Implant debris is known to cause local inflammation, local osteolysis, and, in some cases, local and systemic hypersensitivity. The article describes debris-induced local effects, particle-induced proinflammatory responses, and debris-induced systemic effects. It concludes with a discussion on the four systemic effects of implant debris, namely, neuoropathic effects, hypersensitivity effects, carcinogenictiy, and general toxicity.

The interaction of an implant with the human body environment may result in degradation of the implant, called corrosion. This article discusses the corrosion testing of metallic implants and implant materials. The corrosion environments for medical implants are the extracellular human body fluids, very complex solutions containing electrolytes and nonelectrolytes, inorganic and organic constituents, and gases. The article describes the fundamentals of electrochemical corrosion testing and provides a brief discussion on various types of corrosion tests. It illustrates corrosion current density determination by Tafel extrapolation, potentiodynamic measurement of the polarization resistance, electrochemical impedance measurement, and potentiostatic deaeration. Tests combining corrosion and mechanical forces, such as fretting corrosion tests, environment-assisted cracking tests, and ion-leaching tests are also discussed.

The human internal environment plays a vital role in the friction and wear of implants and prosthetic devices. This article describes the tribological/wear behavior of implants. It discusses the classification of active tribological pairs, namely, amphiarthosis joints and diarthosis joints. The article details the classification of total knee replacement, depending on the type of mechanical stability, including nonconstrained knee replacement, semiconstrained knee replacement, and constrained knee replacement. It also discusses the classifications of passive tribological pairs, namely, total disc replacement in the spine, dental implants, and temporomandibular joint. It describes the various testing methods for characterizing the implant materials used in hip, knee, spine, and dental applications. The article also describes the typical standards used for testing wear behavior of tribological pairs, namely, hip-wear simulation standards, knee-wear simulation standards, and spinal disc-wear simulation standards.

Biomaterials are the man-made metallic, ceramic, and polymeric materials used for intracorporeal applications in the human body. This article primarily focuses on metallic materials. It provides information on basic metallurgy, biocompatibility, chemistry, and the orthopedic and dental applications of metallic biomaterials. A table compares the mechanical properties of some common implant materials with those of bone. The article also provides information on coatings, ceramics, polymers, composites, cements, and adhesives, especially where they interact with metallic materials.

In the field of medical device development and testing, the corrosion of metallic parts can lead to significant adverse effects on the biocompatibility of the device. This article describes the mechanisms of metal and alloy biocompatibility. It reviews the response of implant metals and particulate materials to corrosion. The effect of metal ions from an implanted device on the human body is also discussed. The article concludes with information on the possible cancer-causing effects of metallic biomaterials.

This article discusses the mechanisms of metal and alloy biocompatibility. It provides information on early testing and experience with metals in medical device applications. The article describes the response to severe corrosion of implant and particulate materials. It provides a description of metal binding and its effects on metabolic processes. The hypersensitive responses to metal ions are also reviewed. The article concludes with a discussion on possible cancer-causing effects of metallic biomaterials.

Ion implantation involves the bombardment of a solid material with medium-to-high-energy ionized atoms and offers the ability to alloy virtually any elemental species into the near-surface region of any substrate. This article describes the fundamentals of the ion implantation process and discusses the advantages, limitations, and applications of ion implantation. It also reviews a typical medium current semiconductor implanter adapted for implantation of metals with the aid of illustrations.

This article tabulates materials that are known to have been used in orthopaedic and/or cardiovascular medical devices. The materials are grouped as metals, ceramics and glasses, and synthetic polymers in order. These tables were compiled from the Medical Materials Database which is a product of ASM International and Granta Design available by license online and as an in-house version. The material usage was gleaned from over 24,000 U.S. Food and Drug Administration (USFDA), Center for Devices and Radiological Health, Premarket notifications (510k), and USFDA Premarket Approvals, and other device records that are a part of this database. The database includes other material categories as well. The usage of materials in predicate devices is an efficient tool in the material selection process aiming for regulatory approval.

Surface treatments are used in a variety of ways to improve the material properties of a component. This article reviews information on surface treatments that improve service performance so that the design engineer may consider surface-engineered components as an alternative to more costly materials. It describes solidification surface treatments, such as hot dip coatings, weld overlays, and thermal spray coatings. The article discusses deposition surface treatments such as electro- chemical plating, chemical vapor deposition, and physical vapor deposition processes. Several types of coatings involve a heat treatment either after processing or as part of the coating process. The article describes surface hardening and diffusion coatings, such as carburizing, nitriding, and carbonitriding. It also tabulates typical characteristics of carburizing, nitriding, and carbonitriding diffusion treatments.

This article provides information on thermal spray coating features, which combine to determine the properties of a coating. These include the lamellar or layered splat structure, entrapped unmelted or resolidified particles, pores, oxide inclusions, grains, phases, cracks, and bond interfaces. The article describes the sources of porosity and the factors that control the final coating porosity levels. The article also lists the materials most suitable for thermal spraying processes.

This article summarizes the understanding of the mechanisms and mechanical effects of fatigue processes in highly brittle materials, with particular emphasis on ceramics. It provides a discussion on room-temperature fatigue crack growth in monolithic ceramics, transformation-toughened ceramics, and ceramic composites under cyclic compression. The cyclic damage zones ahead of tensile fatigue cracks, crack propagation under cyclic tension or tension-compression loads, and elevated-temperature fatigue crack growth in monotonic and composite ceramics, are discussed. The article presents ceramic fatigue data for fatigue crack growth testing and concludes with a discussion on life prediction for ceramics or ceramic-matrix composites.

This article presents the principles of chemical vapor deposition (CVD) with illustrations. It discusses the types of CVD processes, namely, thermal CVD, plasma CVD, laser CVD, closed-reactor CVD, chemical vapor infiltration, and metal-organic CVD. The article reviews the CVD reactions of materials related to hard, tribological, and high-temperature coatings and to free-standing structures. It concludes by reviewing the advantages, disadvantages, and applications of CVD.

Aluminum powders can be formed into components by several competing technologies, including powder metallurgy (PM), metal injection molding, powder forging, and additive manufacturing. This article explores PM methodologies that are being exploited to manufacture such components. It reviews emerging technologies that promise to offer exciting ways to produce aluminum parts. The article discusses the various steps involved in PM, such as powder production, compaction, sintering, repressing, and heat treatment. It provides information on aluminum production statistics and the wear-resistance applications of PM.

This article discusses the key factors that influence the selection of engineered materials for a particular application. Materials properties such as ultimate tensile strength, yield strength, hardness, and ductility, which chiefly define the performance or functional characteristics, are covered. This is followed by manufacturing process considerations such as material factors, shape factors, process factors, and the characteristics of fabricability, namely formability, workability, castability, machinability, and weldability.