Medshape Solutions have announced on their website that they have received FDA 510(k) clearance for their DynaNail Intramedullary Fusion Nail. According to the announcement,
“The DynaNail’s unique, patented design utilizes shape memory alloy technology to actively adapt to changes, such as local bone resorption, in the arthrodesis (fusion) site. By adapting to such changes, the DynaNail may better maintain close apposition of the bones and compression across the fusion zone during the healing process.
The DynaNail device, intended for tibiotalocalcaneal arthrodesis procedures, incorporates an innovative shape memory internal element that is simply stretched during the insertion procedure. Once the nail is fixed in place with screws, the shape memory alloy element maintains the target fusion bones in close apposition and under sustained compression for longer time periods than static, non-adaptive intramedullary devices. Surgeons implant the DynaNail using a surgical technique similar to that of traditional ankle fusion nails, thereby dramatically reducing the learning curve required for the new technology.”
This will be the first intramedullary fusion nail on the market that is designed utilizing memory shape alloy technology for use in the Pantalar / Tibiotalocalcaneal Arthrodesis. This will be Medshape Solutions second foot and ankle medical device; they currently carry the Morhpix Bone Anchor.
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