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The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after sternotomy, fracture or dehiscence.

The device consists of a specially shaped clip made of shape memory metal alloy, Nitinol, which is malleable at 10°C and returns to its original shape and stiffness at 27°C. The clip is open on one side and is expanded when cold, placed around the sternum, and returns to shape when warm clamping the sternum together. It is made in a series of 9 sizes from 20 to 40 mm across and 11 to 14 mm deep. The material conforms to the ASTM F2063-05 standard for shape memory alloys and is supplied sterile. Appropriate surgical instruments are also supplied to allow for proper sizing and placement of the clip around the sternum. The Flexigrip Sternal Closure System operates in generally the same manner as stainless steel sutures or any of the listed predicate devices in that it holds the surfaces of the surgically split sternum together after open chest surgery allowing the sternum to heal. Nitinol has a long history of successful implantation in orthopedic and cardiovascular applications dating back to the mid-1970's. The major difference between this device and the predicate devices is that this device does not completely encircle the sternum.