CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 5: 332 - 332-336

DOI: https://doi.org/magtech-2025-07-01-00001

Discussion of Key Attentions on Physical and Mechanical Properties of Ceramic Artificial Hip Joint Products

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  • 1.GBA Center for Medical Device Evaluation and Inspection， NMPA， Guangdong Shenzhen 518045， China；
    2.Center for Medical Device Evaluation， Beijing 100076， China

Received date: 2025-07-01

  Accepted date: 2025-11-27

  Online published: 2025-12-15

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Abstract

Ceramic materials， witch have excellent bio-compatibility， corrosion resistance， and wear resistance， are ideal for manufacturing bearing surfaces of artificial hip joints. According to statistics， ceramic-on-polyethylene and ceramic-on-ceramic artificial hip joint prostheses have been widely used in clinical applications. Compared to conventional metal alloys， many ceramic materials exhibit superior tensile/flexural strength， yet their fracture resistance requires improvement. As there is a risk of fracture failure in clinical applications， necessitating special attention to risk control during the regulatory evaluation process. This study compiles relevant information on ceramic hip joint products and outlines the developmental history of ceramic artificial hip joints in the field of orthopedics. Furthermore， it explores key considerations in the registration and evaluation process by referencing current regulatory requirements and review experiences. The study also summarizes existing mechanical performance evaluation and testing criteria while highlighting the limitations of current assessment methods based on advancements in academic research. The findings aim to serve as a reference for standardizing industry practices and promoting the healthy development of the field.

Key words： ; font-size:medium; ">Ceramic prosthesis； In-vitro evaluation； Hip Joint； Medical device Registration

Cite this article

YANG Shu, ZHAI Bao, ZHANG Jiazhen, DING Jinju, GAO Jintao, LIU Bin . Discussion of Key Attentions on Physical and Mechanical Properties of Ceramic Artificial Hip Joint Products[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(5) : 332 -332-336 . DOI: magtech-2025-07-01-00001

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