Antibiotic-releasing hip stem would be consider a combination device, it will follow in to CDRH based on the primary function of the device which is to replacing the bone. This device will be consider a class 3 because we will implant this in to a human body so definitely we PMA for this device. I said class 3 instead of class 2 because I am assuming this something which will implant inside the body and most important thing we don’t know what kind of drug we are using, so if are using something completely then how the drug will react with the body and does it react with the metal so for all that reason I would say it should be class 3 and it need PMA. I think the claim should be that this device used to support the hip and it also deliver the drug to fight infection to be specific we can say if overcomes immune rejection. For pre-clinical studies I will test it on rats and also perform some test based on ISO 10993-1 and on progress of the project I will file an IDE to test this in Humans.