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MedShape Solutions announces FDA 510(k) clearance of ankle fusion device
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MedShape Solutions Inc. announced in a press release that its DynaNail Intramedullary Ankle Fusion Nail has received 510(k) clearance.
According to a company press release, the DynaNail design uses shape memory alloy technology to actively adapt to changes — such as local bone resorption — in the arthrodesis 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 shape memory internal element that is stretched during the insertion procedure. Once the nail is fixed in place with screws, the shape memory alloy element reportedly maintains the target fusion bones in close apposition and under sustained compression for longer time periods than static, non-adaptive intramedullary devices. According to the release, surgeons implant the DynaNail using a surgical technique similar to that of traditional ankle fusion nails, thereby reducing the learning curve required for the new technology.
“The DynaNail combined the patient compliance and easier postoperative management benefits of internal fixation devices with an external fixator’s ability to keep the bones in the correct healing position and under compression for a longer period of time,” DynaNail co-inventor Doug Pacaccio, DPM, stated in a MedShape release. “The DynaNail offers a dynamic, more patient-friendly alternative to bulky external frames that can present significant patient care issues in the postoperative period.”