Dear colleagues,
For a hip prothesis, a 510(k) must include the complete device: femoral stem, head and acetabular cup, even if the stem has previously been cleared. The manufacturer of a new acetabular cup, for example, must demonstrate compatibility with an existing femoral stem and head. Now, for example, once an acetabular cup has received such a clearance, but the manufacturer wants now to demonstrate compatibility with another femoral stem, which has received its own clearance: can the manufacturer submit a Special 510(k) or must it be a Traditional one? I am trying to see if it could be a Special 510(k) if:
* there is no change in indications for use (which there is no)
* I would argue that there is no change of fundamental scientific technology
Do you agree? Or do yo think that it is too much of a stretch for a Special 510(k)?
Thank you for your experience or recommendation in that area? I am familiar with the various examples given by the Agency to decide if it can be a Special 510(k) (change of material etc...), but I can't figure confidently if this applies to this case or not. Some of you may have already been put in this particular situation.
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Catherine Gloster, MSc, RAC
Gloster Biomedical International
Santa Barbara, CA
United States
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