What kind of regulatory pathway would be required for an antibiotic-releasing hip stem?

The regulatory pathway that would be required for an antibiotic-releasing hip steam is first being reviewed by and approved by the Center for Devices and Radiological Health (CDRH). Since it is a class two device, a 510(k) application can be used. An IDE will be needed.

Is it a device, drug, biologic, or combination?

The antibiotic-releasing hip steam is a combination device of a drug (the antibiotic) and device (hip stem).

What is its “primary mode of action?

The “primary mode” of the antibiotic-releasing hip stem is to replace under performing natural bone and will support the hip in place of the natural bone.

Is it Class I, II, II?

The device is a Class II device.

What claims would you recommend we make for it? An example of a claim is “fights infection in bone (osteomyelitis) and reduces incidence of hip implant failure”. Any claim that you say, you have to lay out a plan to prove it.

The claim that would be recommended is “replaces the natural hip bone, while decreasing infection potential at install location.”

Drawing on some of your experience from the week we did pre-clinical research, what pre-clinical research studies would you recommend be done to prove the claims?

The pre-clinical resesarch studies that I would recommend are all the required tests per the ISO 10993-1 Test Matrix. I would also recommend adding at least the “Irritation or Intracutaneous Reactivity” Test in order to monitor how the antibiotic reacts with the implant in vivo.

Guessing as best you can, what sorts of clinical trials would you recommend in the IDE? Does it need an IDE at all?

I would recommend monitoring how effective the antibiotic is, as well as standard clinical trials for hip stem devices!