TIDAL Fusion Cage System

The TIDAL Fusion Cage System is a titanium alloy implant designed as an accessory to the DynaNail TTC Fusion System for tibiotalocalcaneal (ankle) fusion in salvage procedures following failed ankle arthrodesis or arthroplasty. It features a central clearance hole for the nail and porosity for bone graft packing, and is intended for use with autograft and/or allogenic bone graft in patients at risk of limb loss.

The TIDAL Fusion Cage System is made of titanium alloy (Ti-6Al-4V) and manufactured using additive manufacturing methods. While the primary predicate (DynaNail TTC) uses different materials and manufacturing processes, the subject device's technological characteristics, materials, and manufacturing are identical to the secondary predicate (4WEB Medical Ankle Truss System), which is also titanium alloy made via additive manufacturing.

Not stated in this summary. The document lists benchtop and clinical performance tests (static/dynamic compressive strength, compression-shear strength, torsional strength, fatigue analysis, corrosion testing, and wear particle analysis) but does not cite specific ISO, IEC, or ASTM standards.

The device has the same intended use and identical indications for use (as a subset) to the primary predicate DynaNail TTC Fusion System for tibiotalocalcaneal fusion. Material and manufacturing differences with the primary predicate do not raise different safety or effectiveness questions because the subject device is technologically identical to the secondary predicate (4WEB ATS), demonstrating equivalent performance through benchtop and clinical testing. The central clearance hole design and graft porosity serve the same functional purpose as predicate devices in supporting fusion constructs.