Search Results

Ask a specific question about this device

The DynaNail™ TTC Fusion System is intended for tibio-talo-calcaneal fusions:

• Post-traumatic and degenerative arthritis.
• Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
• Revision after failed ankle arthrodesis with subtalar involvement.
• Failed total ankle arthroplasty.
• Non-union ankle arthrodesis.
• Rheumatoid hindfoot.
• Absent Talus (requiring tibiocalcaneal arthrodesis).
• Avascular necrosis of the talus.
• Neuroarthropathy or neuropathic ankle deformity.
• Neuromuscular disease and severe deformity.
• Osteoarthritis.
• Charcot Foot.
• Previously infected arthrosis, second degree.

The proposed DynaNail™ is a sterile, single use titanium device with an additional internal Nitinol compressive element for use in tibiotalocalcaneal fusions. The DynaNail™'s titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the ankle and subtalar joints postoperatively.

The DynaNail™ is available in 10, 11, and 12mm diameters and lengths of 180mm, 220mm, 260mm, and 300mm. The DynaNail™ is implanted with a deployment frame and fixation screws. The fixation screws are single use 5mm titanium headed and headless screws. The screws are available in lengths that range from 20 to 110mm.

The provided text is a 510(k) Summary for the DynaNail TTC Fusion System, and it describes a medical device, not an AI/ML powered device. Therefore, the information requested in the prompt, which is primarily relevant to the evaluation and validation of AI/ML devices (e.g., acceptance criteria for algorithm performance, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance), is not applicable and cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through design, function, intended use, and adherence to relevant standards like ASTM F 1264-03 for functional performance and ANSI/AAMI ST72 for pyrogenicity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, adjudication methods, or AI/MRMC studies, as these concepts are not part of the described medical device evaluation in this 510(k) summary.

Ask a specific question about this device