Special 510(k) for orthopedic implant

#1
We are planning to expand product line to add a new product with a significant design change . We already have a approved 510k for our current design. Is a Special 510(k) appropriate regulatory pathway ? Please advise.
 
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#3
We are planning to expand product line to add a new product with a significant design change . We already have a approved 510k for our current design. Is a Special 510(k) appropriate regulatory pathway ? Please advise.
Are you sure it's a significant design change?

You can make what appear to be significant changes to the design, without any real changes being made at all
 
#4
Joanne,
That is a smart way to look at it. I reviewed the design again, and its not a significant design change. The change is not impacting the design i/o and no additional validation is required in terms of biocompatibility/sterilization /packaging.
Thanks again for the input.
 
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