Succession™ AFN System

The Succession™ AFN System is a tibiotalocalcaneal (TTC) fusion system comprised of cannulated nails (10-12mm diameter), end caps, and cortical screws made of titanium (Ti-6Al-4V ELI). It is designed to fuse the tibiotalar and subtalar joints together for conditions including failed ankle replacement, ankle/subtalar arthritis, talar avascular necrosis, Charcot, trauma, and rheumatoid arthritis, among others.

The subject device has identical materials (Ti-6Al-4V ELI implants; stainless steel and fluorinated ethylene propylene accessories), chemical composition, manufacturing methods, and similar size range as the predicate Oxford™ Ankle Fusion Nail System. Both utilize gamma irradiation sterilization for implants and equivalent packaging. The Succession™ adds new accessory instruments (extraction adapter, Hudson connection handles, impactor, external compression instrument) but no new body-contacting materials or dissimilar metal contact points.

ASTM F543 Annex A1-A4 (mechanical testing of screw implants for torsional yield strength, driving torque, pullout strength, and self-tapping force); cyclic fatigue testing per Oldenburg et al. methodology for nail bending and torsional strength; comparative corrosion resistance analysis.

The device is substantially equivalent because it maintains identical implant materials, sterilization methods, and design principles as the predicate K121575 (Oxford™/Oxbridge™ AFN System). Mechanical testing demonstrates the Succession™ cortical screws and nails meet or exceed predicate performance in torsional strength, fatigue resistance, and corrosion resistance. The only changes are the trade name and addition of functionally equivalent accessory instruments using the same materials and sterilization methods as the predicate, which do not introduce new safety or effectiveness concerns.