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.

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.

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.

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.

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.

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.

Ceramics are used widely in a number of different clinical applications in the human body. This article provides a brief history of the bioceramics field and discusses the classification of bioceramics. These include bioinert ceramics, bioactive ceramics, and bioresorbable ceramics. The article describes third-generation bioceramics, classified by Hench and Polak, such as silicate-substituted hydroxyapatite and bone morphogenic protein-carrying calcium phosphate coatings. It reviews several examination methods used to test the biocompatibility of ceramics, namely, biosafety testing, biofunctionality testing, bioactivity testing, and bioresorbability testing.

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.

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.

Of the seven additive manufacturing (AM) processes, this article focuses on the vat photopolymerization, or simply vat polymerization, process, while briefly discussing the other six AM processes. Vat polymerization and its characteristics, AM applications in medical fields, and the regulatory challenges of vat polymerization-based bioprinting are presented.

Additive manufacturing, or three-dimensional printing technologies, for biomedical applications is rather different from other engineering components, particularly for biomedical implants that are intended to be used within the human body. This article contains two sections: "Design and Manufacturing Considerations of 3D-Printed, Commercially Pure Titanium and Titanium Alloy-Based Orthopedic Implants" and "Device Testing Considerations Following FDA Guidance" for additive-manufactured medical devices. These are further subdivided into five major focus areas: materials; design, printing, printing characteristics and parameters as well as postprinting validation; removal of the many manufacturing material residues and sterilization; physical, chemical, and mechanical assessments of the final devices; and biological considerations of all the final devices including biocompatibility.

Powder-bed fusion (PBF) is a group of additive manufacturing (AM) processes that includes selective laser sintering, selective laser melting, and electron beam melting. This article explains the processes and parameters of PBF systems that are used for biomedical applications. It also presents the desirable properties of biomedical devices and the advantages of using PBF systems for biomedical applications.

Additive manufacturing (AM), or three-dimensional (3D) printing, has been widely used for biomedical devices due to its higher freedom of design and its capability for mass customization. Additive manufacturing can be broadly classified into seven categories: binder jetting, directed energy deposition (DED), material extrusion, material jetting, powder-bed fusion (PBF), sheet lamination, and vat photopolymerization. Due to their capability for manufacturing high-quality parts that are fully dense, PBF and DED are the most widely used groups of AM techniques in processing metals directly. In this article, the processing of titanium and its alloys by PBF and DED is described, with a specific focus on their use in biomedical devices. The article then covers the density and mechanical properties of both commercially pure titanium and titanium-aluminum-vanadium alloy. Lastly, the challenges and potential of using new titanium-base materials are discussed.

This article describes mechanical/electrochemical phenomena related to in vivo degradation of metals used for biomedical applications. It discusses the properties and failure of these materials as they relate to stress-corrosion cracking (SCC) and corrosion fatigue (CF). The article presents the factors related to the use of surgical implants and their deterioration in the body environment, including biomedical aspects, chemical environment, and electrochemical fundamentals needed for characterizing CF and SCC. It provides a discussion on the use of metallic biomaterials in surgical implant applications, such as orthopedic, cardiovascular surgery, and dentistry. It addresses key issues related to the simulation of an in vivo environment, service conditions, and data interpretation. These include the frequency of dynamic loading, electrolyte chemistry, applicable loading modes, cracking mode superposition, and surface area effects. The article explains the fundamentals of CF and SCC, and presents the test findings from laboratory, in vivo, and retrieval studies.

This article provides information on biomedical aspects such as active biological responses and the chemical environment characterizing the internal physiological milieu, as well as electrochemical fundamentals needed for characterizing corrosion fatigue (CF) and stress-corrosion cracking (SCC). It discusses some of the mechanical and electrochemical phenomena related to the in vivo degradation of materials used for biomedical applications. These materials include stainless steels, cobalt and titanium-base alloy systems, and dental amalgam. The article addresses key issues related to the simulation of the in vivo environment, service conditions, and data interpretation. The factors influencing susceptibility to CF and SCC are reviewed. The article describes the testing methodology of CF and SCC. It also summarizes findings from laboratory testing, in vivo testing and retrieval studies related to CF and SCC.

This article focuses on the directed-energy deposition (DED) additive manufacturing (AM) technique of biomedical alloys. First, it provides an overview of the DED process. This is followed by a section describing the design and development of the multiphysics computational modeling of the layer-by-layer fusion-based DED process. A brief overview of the primary governing equations, boundary conditions, and numerical methods prescribed for modeling laser-based metal AM is then presented. Next, the article discusses fundamental concepts related to laser surface melting and laser-assisted bioceramic coatings/composites on implant surfaces, with particular examples related to biomedical magnesium and titanium alloys. It then provides a review of the processes involved in DED of biomedical stainless steels, Co-Cr-Mo alloys, and biomedical titanium alloys. Further, the article covers novel applications of DED for titanium-base biomedical implants. It concludes with a section on the forecast of DED in biomedical applications.

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.