Arthrex DynaNite Nitinol Staples

The Arthrex DynaNite Nitinol Staples are nickel-titanium bone fixation devices designed for permanent implantation. They are indicated for fixation in foot and hand surgery (including arthrodesis, osteotomies, and fracture fixation), small bone fragments throughout the skeleton, and sternotomy closure when used with cerclage sutures. The devices have two legs connected by a bridge in multiple size combinations.

The proposed devices are identical in technological characteristics to the predicate, including device design, sterilization, packaging, and biocompatibility. The only modification is the addition of sternotomy indications for specific sizes (13x10 and 15x12) when used with Arthrex FiberTape Cerclage System.

Cyclic/fatigue construct testing per FDA guidance; MRI testing per ASTM F2052, F2119, F2182, and F2213 for displacement force, image artifacts, and radio frequency heating; bacterial endotoxin per EP 2.6.14/USP <85>; and FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

The device is substantially equivalent because the basic design features and mechanical function remain identical to the predicate device; only the indication has expanded to include sternotomy use. Performance testing demonstrates the device performs equivalently to cerclage sutures in sternal closure constructs, and MRI and safety testing confirm no new hazards arise from the expanded indication for this anatomical site.