The path of an antibiotic releasing hip stem would certainly start out with an RFD. Although the primary function of this device is the physical hip stem, the antibiotic releasing portion is the aspect of the device that would make it class 3. If it were just a hip stem, it would be class 2. If found that it falls under CDER, the pathway would include and IND, phase trials, and an NDA. However, I would argue that the hip stem portion also warrants a 510(k). The device would get an NDA because the antibiotic portion is the class 3 component, not the stem. The claims that trials should back up are that the antibiotics reduce the rate of infection post-surgery, it does not reduce bone adhesion, and the antibiotics mitigate an immune reaction against the hip stem. This could use in vitro and in vivo clinical trials on pigs. Rats/mice would be unfeasible due to the small proportions.