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The Arthrex DynaNite Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bicortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The Arthrex DynaNite Compression Plate is intended to be used in conjunction with the Arthrex Compression FT Screws.

The Arthrex DynaNite Compression Plate is an implant with a number of threaded holes and a central region of articulating arms. Sizes range from approximately 15 to 30mm in hole-to-hole distance. Geometrically, the plate is offered in straight, 'T-shape', and 'X-shape' configurations. The Arthrex DynaNite Compression Plate is sold attached to a clamp delivery device, which constrains the implant in an elongated state, along its long axis. The clamp delivery device is removed after screw fixation is achieved, which in turn causes the plate to return to its original confirmation (shape memory effect), shortening along its long axis and generating compression. The Arthrex DynaNite Compression Plate is sold as sterile and is single-use. The Arthrex DynaNite Compression Plate is to be used with the Arthrex 3.0 mm Titanium VA Locking Screws and Locking Screws cleared under K143614 and K150456.

The provided text is related to a 510(k) premarket notification for a medical device called the "Arthrex DynaNite Compression Plate." This submission confirms that the device is substantially equivalent to legally marketed predicate devices, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document.

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