What Should Be Considered In Performance Evaluation Of The Individual Component Of Artificial Joint Products During Registration Application As A Single Component?

Artificial joint products are usually used as a whole to replace human joints. When the product registration contains only a single component, in addition to evaluating the performance of the component, it is also necessary to provide the product information of other components used in conjunction with the component under application, and evaluate through studies the performance of the interaction between the component under application and the cooperating component and the performance of the system as a whole. Take the artificial hip joint system as an example, if the product registration is for femoral stem, performance study data of the femoral head matched with it should be provided at least. If the product registration is for the acetabular liner, performance study data of the acetabular cup and femoral head matched with it should be provided at least; as it is related to the articular surface, the overall wear performance study of the system should be provided.