Your question is highly dependent on the specific device at issue and whether its approved indication covers how it is surgically place (cemented versus non-cemented) and so unfortunately we are not able to provide a specific answer.
However, the use of an approved medical device in a clinical investigation is exempt from the IDE regulations if the device is being used or investigated in accordance with its FDA approved indications. See 21 CFR 812.2(c)(2). Any analysis of whether an IDE may be required should start with the approved indication and if questions remain a consult with the FDA should be sought. If the FDA makes a determination that the use of the device is exempt, the agency’s determination is final and IRB’s are resolved of this obligation.
