DynaNail TTC Fusion System

The DynaNail TTC Fusion System is an intramedullary nail device used in tibiotalocalcaneal fusion surgeries to treat various ankle and hindfoot conditions including arthritis, non-unions, avascular necrosis, and deformities. The system consists of a nitinol and titanium nail, end cap, screws, and deployment frame that are implanted into the medullary canal of the tibia, talus, and calcaneus.

The proposed device maintains the same technological and performance characteristics as its predicate, with design modifications to the nitinol compressive element, nail outer body, and deployment frame to accommodate pre-stretching of the nitinol in manufacturing rather than in the operating room. The addition of an 'MR Conditional' labeling claim for magnetic resonance imaging compatibility is also included.

Static Strain Test per ASTM 2516, Free Recovery Testing per ASTM F2082, Fatigue Strain Test per ASTM E606 and ASTM F2516, Corrosion Test per ASTM 2129, and MR Testing per ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119.

The device is substantially equivalent because it maintains identical fundamental design, materials, intended use, and performance characteristics as the predicate device (K171376). The design modifications—pre-stretching the nitinol and updating the compressive element, nail body, and deployment frame—do not raise new safety or effectiveness questions, and the MR Conditional labeling addition is supported by testing per established MR safety standards. Non-clinical testing confirmed equivalent performance between proposed and predicate designs.