For an antibiotic-releasing hip-stem
Device Type: combination device
The primary mode of action: Hip-stem, structural replacing a bone- holding up a hip.
Agency has governance over it: CDRH
Class: Class II
Regulatory Pathway: CDRH->Class II-> 510(k)
510(k) defined “is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval”
Claim: Replaces bone of a hip with enhanced titanium steel structure as substantially equivalent titanium hip stem prosthetic devices
For a CDRH-> Class II, No IDE is required. If it was a CDRH/Class III then yes it would require and IDE/Pivotal Trials/PMA