SnapHammer Hammertoe Correction System

The SnapHammer Hammertoe Correction System is a titanium bone fixation screw used to repair and stabilize the lesser toes after hammertoe, claw toe, or mallet toe correction procedures. The implant features a snap-off post for ease of insertion and is available in two diameters (3.0mm and 3.5mm) and lengths from 12mm to 15mm. Cannulated versions can accommodate K-wires for temporary joint stabilization.

The subject device is additively manufactured titanium with a snap-off post attachment, offered in Ø3.0mm and Ø3.5mm diameters and 12-15mm lengths. The modification from the predicate adds steam sterilization as an alternative sterilization method validated to ISO 17665-1 and 17665-2 standards (sterility assurance level 10⁻⁶). Associated instruments (drills, inserters, sizers) are medical-grade stainless steel, unchanged from the predicate.

ISO 17665-1 and ISO 17665-2 for steam sterilization validation demonstrating sterility assurance level of 10⁻⁶. No FDA performance standards are established for this device class.

The device maintains identical features, materials, intended use, and indications as the previously cleared predicate (K231453). The only modification is the addition of steam sterilization as an alternative sterilization method, which is a standard practice for medical devices and does not alter device performance or intended use. Engineering analysis confirms that cleaning and sterilization process changes do not raise new safety or efficacy concerns, making the modified device substantially equivalent to the predicate.