Histopathological Evaluation of Orthopedic Medical Devices: The State-of-the-art in Animal Models, Imaging, and Histomorphometry Techniques

Toxicol Pathol. 2019 Apr;47(3):280-296. doi: 10.1177/0192623318821083. Epub 2019 Jan 17.


Orthopedic medical devices are continuously evolving for the latest clinical indications in craniomaxillofacial, spine, trauma, joint arthroplasty, sports medicine, and soft tissue regeneration fields, with a variety of materials from new metallic alloys and ceramics to composite polymers, bioresorbables, or surface-treated implants. There is great need for qualified medical device pathologists to evaluate these next generation biomaterials, with improved biocompatibility and bioactivity for orthopedic applications, and a broad range of knowledge is required to stay abreast of this ever-changing field. Orthopedic implants require specialized imaging and processing techniques to fully evaluate the bone-implant interface, and the pathologist plays an important role in determining the proper combination of histologic processing and staining for quality slide production based on research and development trials and validation. Additionally, histomorphometry is an essential part of the analysis to quantify tissue integration and residual biomaterials. In this article, an overview of orthopedic implants and animal models, as well as pertinent insights for tissue collection, imaging, processing, and slide generation will be provided with a special focus on histopathology and histomorphometry evaluation.

Keywords: ISO 10993-6; animal models; histologic processing; histomorphometry; histopathology; medical devices; orthopedic materials.

Publication types

  • Review

MeSH terms

  • Absorbable Implants / adverse effects*
  • Absorbable Implants / standards
  • Animals
  • Biocompatible Materials / standards*
  • Bone-Anchored Prosthesis / adverse effects*
  • Bone-Anchored Prosthesis / standards
  • Equipment Design / standards*
  • Histological Techniques / methods*
  • Materials Testing / methods
  • Models, Animal*


  • Biocompatible Materials