September 2011

FDA clears DynaNail for ankle fusion

Atlanta, GA-based medical device company MedShape Solutions announced in August that it has received 510(k) market clearance from the Food and Drug Administration for its DynaNail, an intramedullary fusion nail intended for tibiotalocalcaneal arthrodesis procedures.

The DynaNail incorporates a shape memory internal element that is stretched during the insertion procedure. Once the nail is fixed in place with screws, the shape memory alloy maintains the target fusion bones in close apposition and under sustained compression for longer periods than static nonadaptive intramedullary devices. Surgeons implant the DynaNail using a technique similar to that of traditional ankle fusion nails, reducing the learning curve required for this new technology.

The device’s inventor noted the DynaNail combines 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  time.

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