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The Synthes FlexNail is intended for treatment of humeral shaft fractures; specifically, it is for treatment of acute humeral shaft fractures, including certain pre- and post-isthmal fractures (including, but not limited to transverse, short oblique, long oblique, butterfly, and segmental fractures, of all grades of comminution); pathologic or impending pathologic fractures; and non- and malunions of the humeral shaft.

Synthes FlexNail is a flexible, non-reamed, locking intramedullary fixation device that is capable of sharing normal weight-bearing loads with the fixed fractured humerus. It locks within the medullary canal at either end of the bone, bridging the fracture and maintaining alignment while the fracture heals. It is available in 7.0, 7.5 and 9 mm diameters, in lengths ranging from 180 to 300 mm (in 15 mm increments). Nail accessories include: a 3.9 mm Ti Locking Bolt for nail interlocking; a Tension Screw that mates with the tension block; and End Cap Screws. The "0 mm" extension End Cap Screw is used to plug the proximal connecting thread of the nail and prevent tissue in-growth to facilitate removal. The "15 mm" extension End Cap Screw protects the proximal thread of the nail and holds the proximal extension segment to the nail. This allows the nail to be overinserted by 15 mm, while leaving the proximal end of the nail accessible for removal. The FlexNail is manufactured from a titanium alloy.

This document is a 510(k) summary for the Synthes FlexNail, an intramedullary fixation rod for humeral shaft fractures. It establishes substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria or the study that proves the device meets such criteria.

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