Magnesium alloys: A stony pathway from intensive research to clinical reality. Different test methods and approval-related considerations.
The first degradable implant made of a magnesium alloy, a compression screw, was launched to the clinical market in March 2013. Many different complex considerations are required for the marketing authorization of degradable implant materials. This review gives an overview of existing and proposed standards for implant testing for marketing approval. Furthermore, different common in vitro and in vivo testing methods are discussed. In some cases, animal tests are inevitable to investigate the biological safety of a novel medical material. The choice of an appropriate animal model is as important as subsequent histological examination. Furthermore, this review focuses on the results of various mechanical tests to investigate the stability of implants for temporary use. All the above aspects are examined in the context of development and testing of magnesium-based biomaterials and their progress them from bench to bedside. A brief history of the first market launch of a magnesium-based degradable implant is given. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 329-347, 2017.
Department of Orthopedic Surgery, Hannover Medical School, NIFE, Lower Saxony Centre for Biomedical Engineering, Implant Research and Development, Stadtfelddamm 34, 30625, Hannover, Germany.
Elmar
E
Willbold
Department of Orthopedic Surgery, Hannover Medical School, NIFE, Lower Saxony Centre for Biomedical Engineering, Implant Research and Development, Stadtfelddamm 34, 30625, Hannover, Germany.
Andreas
A
Weizbauer
Biocompatibility Laboratory BioMedimplant, Stadtfelddamm 34, 30625, Hannover, Germany.
Anneke
A
Loos
Syntellix AG, Aegidientorplatz 2a, 30159, Hannover, Germany.
Jan-Marten
JM
Seitz
Department of Orthopedic Surgery, Hannover Medical School, NIFE, Lower Saxony Centre for Biomedical Engineering, Implant Research and Development, Stadtfelddamm 34, 30625, Hannover, Germany.
Nina
N
Angrisani
Department of Orthopedic Surgery, Hannover Medical School, NIFE, Lower Saxony Centre for Biomedical Engineering, Implant Research and Development, Stadtfelddamm 34, 30625, Hannover, Germany.
Henning
H
Windhagen
Department of Orthopedic Surgery, Hannover Medical School, NIFE, Lower Saxony Centre for Biomedical Engineering, Implant Research and Development, Stadtfelddamm 34, 30625, Hannover, Germany.
Janin
J
Reifenrath
D020341:Absorbable Implants; D000497:Alloys / Q000737:chemistry / Q000627:therapeutic use; D000818:Animals; D006801:Humans; D008274:Magnesium / Q000737:chemistry / Q000627:therapeutic use
D000497:Alloys; D008274:Magnesium
biomechanics; degradation; implants; magnesium; orthopedic; standards