Device: Antibiotic-Releasing Hip Stem
Type: Combination of a device (hip stem component) and a drug (antibiotic component) but the primary mode of action is as the hip implant. This product will then need a Request For Designation (RFD) to allocate it to whichever department the FDA deems appropriate. This will most likely be the Center for Devices and Radiological Health (CDRH) since it is primarily a device, which you will have to make that case with a strong argument.
Class: I would determine this to be a Class II product since it is not life sustaining/supporting and also is not a novel idea, it only adds the extra healing component to an already existing concept.
Claims/Trials: Since the hip implant is already proven to be effective on its own, we should test the antibiotic agent on different animals in case which they may have broken bones or modified implants of their own. A control group will not be given the healing agent and the experimental group will. Whichever benefits can be seen in the experimental group should be used as claims for this product.
Approvals: This product will need an IDE since it introduces new risk to the patient and will need to be evaluated in human trials before gaining market approval.