TX Q&A

Metal bone pins include both fully implantable metal bone pins and those used in conjunction with external fixation frames. Metal bone pins designed for use with external fixation frames can be part of the same registration unit as the external fixation frame they are intended to be used with. This registration unit does not include fully implantable metal bone pins. Metal bone pins used with external fixation frames and fully implantable metal bone pins can be declared under the same registration unit. Guide pins used for positioning during surgery are considered surgical tools and belong to a different registration unit than internal fixation products.

The aspects that need to be compared are related to the product characteristics. Performance indicators in the technical requirements are usually important indicators describing the product characteristics and generally need to be compared. Whether it is a key parameter should be determined based on the specific situation of the product.