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The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.

The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum. The predicate device was originally made of PEEK-OPTIMA™. This 510(k) introduces a new variant of the product made of carbon-fiber reinforced (CFR) PEEK-OPTIMA™. This new variant also presents some minor geometry changes with respect to the predicate device, to adapt the product to the new material.

The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.

The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum.