In regards to the antibiotic-releasing hip-stem implant this medical device would be considered a combination device since the product has two functionalities; however the overall primary mode of action is that of a hip-stem, to structurally support the hip. Since this product falls under a medical device, the government agency that would oversee and make decisions would be CDRH. This device would be a class II medical device since it has a special control being antibiotic release to lower the percentage of body rejection. The Regulatory pathway would be CDRH -> RFD -> Class II > 510 (k). The claim for this device would be just that it helps in supporting the hip by using a titanium steel structure or chromium cobalt and is coated with an antibiotic agent to fight off infection in the bone and reduces the hip failure due to body rejection. Any further claims for the device could be used against the company if not proven and the FDA would raise further questions about the product which could make this device a possibly class III if it has further other utilities that is unique to the hip-stem market. By matching this device in terms of materials with other predicate devices in the market would allow this device to receive a 510 (k). Since this product is a class II it does not need an IDE, only it the device would be a class III or could not file for a 510 (k) which would lead this device to file for a PMA which would be accompanied by an IDE and clinical trials.