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The DePuy Synthes Hammertoe Continuous Compression Implant is indicated for small bone reconstruction and fusion of the phalanges in the toes.

The implants of the DePuy Synthes Hammertoe Continuous Compression Implant System are made of biocompatible Nitinol and are designed to exhibit pseudoelastic (superelastic) properties at room temperature. Each implant is supplied pre-loaded on an insertion stick assembly in a constrained state, with the legs parallel. It is inserted into pre-drilled holes and released utilizing the insertion slider and if necessary, impaction on the proximal end of the insertion stick. Upon release, the implants attempt to return to their original unconstrained shape and thus provide compression to the bones across the osteotomy or arthrodesis site. The implants do not require any external heating; they are completely transformed at ambient temperature. In good bone quality, this deflection may not be visible as the legs are constrained by the surrounding tissue. The implant is offered in two (2) sizes to address varying patient anatomy of the foot. The implant is delivered to the operating room in a disposable, sterile kit, preloaded onto a handheld insertion stick assembly along with a drill pin, drill guide, locator pins and K-wires.

The provided text is a 510(k) summary for the DePuy Synthes Hammertoe Continuous Compression Implant. It outlines the device description, indications for use, comparison to predicate devices, and non-clinical performance data.

However, it explicitly states:

"Clinical testing was not necessary for the determination of substantial equivalence."

This means that a study proving the device meets specific acceptance criteria based on clinical performance was not performed, nor was it required for this 510(k) clearance. The clearance was based on demonstrating substantial equivalence to existing legally marketed predicate devices through technological characteristics and non-clinical testing.

Therefore, I cannot provide the requested information, which pertains to clinical acceptance criteria and a study demonstrating their achievement, as such a study was not conducted for this device clearance.

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