Unicondyle Knee Prosthesis


Product NameUnicondyle Knee Prosthesis
ClassificationClass III
Review DivisionCenter for Medical Device Evaluation of NMPA
Applicant NameBeijing Chunlizhengda Medical Instruments Co., Ltd.
Registration PathwayDomestic Device
Innovation Pathway
Product DescriptionThe unicondyle knee prosthesis consists of femoral condyle and assembled tibial platform which is composed of tibial platform pad and tibial platform support. The femoral condyle and tibial platform support are made of cast cobalt chromium molybdenum alloy material in accordance with YY 0117.3 standard, the tibial platform pad is made of type 2 ultra-high molecular weight polyethylene material in accordance with GB / T 19701.2 standard, and the developing needle in the tibial platform pad is made of TC4 titanium alloy material in accordance with GB / T 13810 standard. The product is sterilized by irradiation with  a period of validity of 5 years.
Indications for UseThis product can be used in combination with bone cement for replacement of unilateral condyle of knee joint.
Summary of Non-Clinical TestingThe applicant submitted the following non-clinical research materials:
• Product performance research
• Biocompatibility
• Sterilization
• Product shelf-life and packaging

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Summary of Clinical Evaluation • Clinical pathway: CER pathway
The registrant submitted the clinical evaluation data in accordance with the requirements of the Technical Guidelines for Clinical Evaluation of Medical Devices, proving that the to-be-registered product is basically the same as the medical devices of the predicate. For the dissimilarities, the equivalent supporting data of mechanical property ratio is submitted to prove that the dissimilarities do not affect the clinical safety and efficacy.  

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Product Risk/Benefit AnalysisThe registrant shall conduct risk analysis on the product according to YY / T 0316-2016 Application of Medical Device Risk Management to Medical Devices. Risk control measures have been taken for the currently known and predictable risks. Through comprehensive evaluation, it is considered that the benefits brought by the listing of the product outweigh the risks at the current cognitive level. In order to ensure the safety of machinery, the following information shall be prompted in the IFU:  
• Warnings and precautions
• Contraindications
• Others

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