Most likely that the new 510 (k)s will just be for new sizes or perhaps a different thickness.
But I was wondering about whether 510(k) clearance might be sought for BTM/MTX in new indications.
Repair of scar contracture is a separate indication for which Integra’s dermal template has been approved by the FDA. I believe the potential suitability of BTM for scar contracture repair has already been discussed.
Another indication for which 510(k) clearance might possibly be sought is rotator cuff repair, given the numerous mentions of orthopaedics and rotator cuffs over the past couple of years. There are 17 million people with rotator cuff disease in the US alone. There are already a few products on the market with clearance for tendon reapir/reinforcement, such as Smith and Nephew’s Regeneten, which is also used in treating Gluteus Medius and Achilles tears in the US.
Other than the fact that Regeneten is a collagen-based product (bovine), I can’t see why BTM couldn’t perform the same function?
https://smith-nephew.com/en-us/heal...neten-bioinductive-implant#surgicaltechniques
https://www.smith-nephew.com/en-us/...test-innovations-at-2022-aossm-annual-meeting
(20min delay)