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The Succession™ Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

• Failed ankle replacement
• Arthritis of ankle and subtalar joint
• Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
• Revision of failed ankle and/or subtalar fusion
• Revision of failed Tibiotalocalcaneal (TTC) fusion
• Talar Avascular Necrosis (AVN)
• Charcot
• Trauma
• Neuroarthropathy
• Pseudoarthrosis
• Rheumatoid arthritis

The Succession™ AFN System is comprised of a set of straight 10mm, 11mm, and 12 mm diameter cannulated nails, 12.5mm diameter end caps, 5mm and 6mm diameter cortical screws, and accessory instrumentation. All implants are composed of Titanium (Ti-6Al-4V ELI) and provided to the user sterile packed with a combination of both sterile and non-sterile accessory instrumentation to assist in implantation. Each of the accessory instruments provided with the subject device contain substantially equivalent materials to the Oxford™ Ankle Fusion Nail System predicate device instrumentation, including stainless steel (ASTM F899 and ASTM F138 / ISO 5832-1) and Fluorinated Ethylene Propylene direct contacting materials.

During the procedure, following preparation of the tibial intramedullary canal (using the device accessory instrumentation) and placement of the intramedullary fixation nail, the provided 5mm screws are inserted into the medial to lateral (M/L) slots of the implant, allowing for fixation in the tibia, talus, and calcaneus. In both the talus and calcaneus, dynamic compression slots are included in the nail and are to be used with the internal and/or external methods of compression across the tibiotalar and subtalar joints. In addition, a 6mm screw is placed through the only angled posterior to anterior (P/A) slot located at the distal end of the nail implant, allowing for additional fixation between the calcaneus and talus. Following the placement of all screws, the end caps are implanted to add stability to the distal end of the nail and prevent excess bony ingrowth from occurring within the nail cannulation. Overall, the Succession™ Ankle Fusion Nail is intended to effectively fuse the tibiotalar and subtalar joints together, providing stability in the hindfoot region to facilitate tibiotalocalcaneal arthrodesis.

Based on the provided FDA 510(k) Clearance Letter, the Succession™ AFN System is an intramedullary fixation rod, and the clearance is primarily based on substantial equivalence to predicate devices. This means the device is demonstrated to be as safe and effective as a legally marketed device, not necessarily by proving it meets specific quantitative performance acceptance criteria for an AI/machine learning device.

The document provided does not contain information about an AI/ML-driven device's acceptance criteria or a study proving its performance. The "Non-Clinical and/or Clinical Tests Summary" in the document describes mechanical testing of the physical device (nails, screws, and accessories) for properties like torsional yield strength, driving torque, pullout strength, self-tapping force, cyclic fatigue, bending strength, torsional strength, and corrosion resistance.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The provided text is solely about the substantial equivalence of a physical orthopedic implant.

If this were a document about an AI/ML device, the sections you requested would typically be found in a "Performance Benchmarking" or "Clinical Study" section, detailing the AI's accuracy, sensitivity, specificity, or impact on human performance, along with the study methodology.

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