Replacement Bone Screws - Traditional 510(k) or Special 510(k)?

[fcowdery]

Good afternoon-
Im reaching out for opinion on whether to file a Traditional 510(k) or Special 510(k).

Our device, which has been cleared, includes Bone Screws. The Bone Screws are single use devices (consumables).
Because these Bone Screws are "Consumables", we would like to supply replacement Bone Screws to our customers as required.

To do this we need to submit a separate 510(k) to the FDA for only the bone screws.
Since there would be no change in technology or Indications, we feel Special 510(k) would be sufficient.

Thanks for your guidance.

 

[Ronen E]

To do this we need to submit a separate 510(k) to the FDA for only the bone screws.

Why do you think so?
Normally replacement parts, identical to parts included in a whole-device submission, do not require an additional submission.
Doesn't the original submission address the replacement aspect of the intended use?

 

[fcowdery]

Hello Ronen
We believe we do because the Bone Screw, by itself, is considered a Class 2 medical device by FDA.
It was cleared previously as part of our system but not as an individual component.
The original submission did not address the replacement aspect, only the intended use with our system.

 

[craiglab]

When you say "replacement bone screws" this implies replacement for their use as intended with the cleared device.
If that is the case then use the FDA guidance "when to submit a change" found here:
Deciding When to Submit a 510(k) for a Change to an Existing Device
As you go through it, document why yes or no and what evidence supports the decision. This exercise should answer to file or not for the replacement offering. If the reason for filing is because the screws are for a different intended use then traditional 510(k).

 

[fcowdery]

The bone screws are single use, not reprocessed. The Bone Screw Intended Use does not change.
A small quantity is provided with the purchase of each system.
Once a doctor has consumed the quantity provided with our system, they would ned to purchase an additional quantity.
We, the OEM, would like to sell / distribute more of the original bone screws.

The FDA has indicated for us to distribute the bone screws, a separate clearance would be required.

 

[Watchcat]

As an RA professional, I hate dealing with parts of anything. Also accessories, kits, ugh. Give me a good solid PMA device any day. So I don't know what you need to do for this particular situation. I do know that there is quite a difference between providing customers with a true replacement part, which is needed when the original part breaks, wears out, or is damaged, and which may be provided at no charge under a warranty, and simply selling customers more consumables. Further, I know that there is an even bigger difference if the consumable can be used by customers without using your device.

 

[Ronen E]

The use of "replacement" here is misleading. We are discussing straightforward consumables (that are devices).
If the FDA indicated a separate clearance it's a no-brainer. Unless the FDA has said otherwise, I'd think it should be a Traditional 510k. A Special 510k is always about a change relative to a predicate, so what would the change be here? Removal of the parent device and leaving only the screws in scope?

 

[fcowdery]

I agree Ronen. There really is no change to the device.
Since there is a separate reg for bone Screws, we have decided a Traditional 510k is probably the best approach.
Thanks everyone for your inputs.