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.

Metallography plays a significant role in the quality control of metals and alloys used in the manufacture of implantable surgical devices. This article provides information and data on metallographic techniques along with images showing the microstructure of biomedical orthopedic alloys, including stainless steels, cobalt-base alloys, titanium and titanium alloys, porous coatings, and emerging materials.

This article focuses on the analysis of materials and mechanical- (or biomechanical-) based medical device failures. It reviews the failure analysis practices, including evidence receipt, cleaning, nondestructive examination, destructive examination, exemplars analysis, and device redesign. The article examines the common failure modes, such as overload, fatigue, corrosion, hydrogen embrittlement, and fretting, of medical devices. The failure analysis of orthopedic implants, such as permanent prostheses and internal fixation devices, is described. The article reviews the failure mechanisms in some of the more common medical device materials, namely, stainless steels, titanium alloys, cobalt-base alloys, and nitinol. It presents case histories with examples for failure analysis.

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 applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes 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 examples of biomaterials applications, such as endovascular devices, knee implants, and neurostimulation.

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

Titanium and its alloys have been used extensively in a wide variety of implant applications, such as artificial heart pumps, pacemaker cases, heart valve parts, and load-bearing bone or hip joint replacements or bone splints. This article discusses the properties of titanium and its alloys and presents a list of titanium-base biomaterials. Titanium components are produced in wrought, cast, and powder metallurgy (PM) form. The article describes forging, casting, and heat treating of titanium alloys for producing titanium components. Typical mechanical properties of titanium biomedical implant alloys are listed in a tabular form. The article presents an overview of the surface-modification methods for titanium and its alloys implants. It concludes with a section on biocompatibility and in vivo corrosion of titanium alloys.

Physically, tantalum is a dark, blue-gray, lusterless metal that exists in two crystalline forms: an alpha-phase with a body-centered cubic structure, and a brittle beta-phase with a tetragonal orientation. This article tabulates the physical and material properties of tantalum. It discusses the use of tantalum in medical electronics and the advantage of tantalum over stainless steel. The article describes the manufacturing and medical applications of tantalum foam.

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

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.

This article reviews the corrosion interactions between biomedical alloys, in particular iron-base, titanium-base, and cobalt-base alloys, in complex geometries and in applications where there are significant cyclic stresses and potential for wear and fretting motion. It discusses the nature of these metal surfaces and their propensity for corrosion reactions when combined with similar or different alloys in complex restrictive environments within the human body and under loading conditions. The article describes the factors that influence mechanically assisted crevice corrosion. It reviews the tests developed to investigate the aspects of mechanically assisted corrosion of metallic biomaterials: the scratch test and the in vitro fretting corrosion test.

Polymers offer a wide range of choices for medical applications because of their versatility in properties and processing. This article provides an overview of polymeric materials and the characteristics that make them a unique class of materials. It describes the ways to classify polymers, including the polymerization method, how the material deforms, or molecular origin or stability. The article contains tables that list common medical polymers used in medical devices. It explains the medical polymer selection criteria and regulatory aspects of materials selection failure analysis and prevention. Failure analysis and prevention processes to determine the root cause of failures that arise at different stages of the product life cycle are reviewed. The article describes the mechanisms of plastic product failure analysis. It discusses the trends in the use of medical polymers, such as high-performance polymers for implants, tissue engineering, and bioresorbable polymers.

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 metals/coatings having an open-cell structure, high porosity, and a microstructure resembling that of the 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 metals/coatings that have been developed due to the limitations of traditional porous metals for numerous open-cell-structured metals, such as titanium-base foams and trabecular metals.

This article reviews the concepts considered important for an understanding of the processes used for preparing cobalt-chromium alloy implants, the microstructures resulting from this processing, and the resulting material properties. The review includes solidification of alloys, diffusionless (martensitic) phase transformation as occurs with face-centered cubic to hexagonal close-packed transformation in cobalt-chromium alloys, and stacking faults and twins and their role in this transformation. It also discusses the strengthening mechanisms that are responsible for the mechanical properties of cast and wrought cobalt alloys. The article contains tables that list the commonly used cobalt alloys and their biomedical applications and chemical compositions. It discusses the mechanical and corrosion properties of cobalt alloys, and provides a description of the microstructure of cobalt alloys.

This article describes the corrosion resistance and ion release from main transition metallic bearings used as medical devices. It discusses the main issues associated with the in vivo presence of ions and their biocompatibility during the exposure of patients to different aspects of ion toxicity. These include ion concentration and accumulation in organisms, reactive oxygen species and oxidative stress, and carcinogenicity stimulated by the corrosion process and toxic ions release.

This article focuses on the specific aspects of nitinol that are of interest to medical device designers. It describes the physical metallurgy, physical properties, and tensile properties of the nitinol. The article discusses the factors influencing superelastic shape memory effects, fatigue, and corrosion in medical device design. It reviews the biocompatibility of nitinol based on corrosion behavior. The article explains the general principles, potential pitfalls, and key properties for manufacturing, heat treatment, and processing of nitinol.

This article provides an overview of how thermal spray technology has adapted to meet the needs of the orthopaedic industry. It includes the challenges facing the development of artificial joints, substrate material selection criteria, thermal spray solutions, and clinical outcomes of thermal spray coatings. The article focuses on plasma thermal spray, which is the technique most often used to make porous titanium and hydroxyapatite (HA) coatings, such as thermal spray titanium, thermal spray HA, solution-precipitated HA, thermal spray chromium oxide, and thermal spray chromium carbide cermet coatings.

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 the properties and hard-tissue response to particular clinical applications. The article also provides information on the glass or glass-ceramic particles used in cancer treatments.

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.

This article provides a background to the biological evaluation of medical devices. It discusses what the ISO 10993 standards require for polymeric biomaterials and presents examples of qualitative and quantitative tests that can be used to satisfy these requirements. The article describes infrared (IR) and thermal analyses that are used extensively to fingerprint polymeric materials. It also presents a discussion on the chemical characterization and risk assessment of extracts. Background information on risk assessments of extracts is also included. The four basic steps that are commonly used in the risk assessment process are discussed. These include hazard identification, dose-response assessment, and exposure assessment, and risk characterization.

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