1. Biological Effect: In Vivo Tests
2. Turnaround time: 12 or 21 weeks or more (after approval from Local Ethics Committee)
3. Sample Requirements:
to be individually determined;
4. Animal Quantity: 10 or 5 or 3 rabbits (depending on the number of implantation sites)
5. Duration of implantation: 4 weeks or 13 weeks or to be individually determined
The purpose of the study is to evaluate the medical device for local effects on living tissue when implanted in rabbit femurs. Test item is implanted at the distal, medial, and proximal locations of the femur. The bioreactivity of a test item is determined through microscopic and macroscopic comparison of the tissue response caused by the medical device as compared to an appropriate control material. The area of the tissue surrounding the center position of each implant will be processed and a histopathologist will process the implanted sites for histopathological evaluation.