Table 2.

Patient protection procedures recommended by the Food and Drug Administration for use of a custom device in joint replacement surgery.

Informed consent from the patient or a legal representative. Clearance from the institution as specified by institutional policies. Concurrence by the IRB chairperson. Assessment from a physician (orthopaedic surgeon) who is not biased concurring with plan to use the custom component. Authorization from the investigational device exemption (IDE sponsor) if an IDE exists for the device.