Initia T3 Acetabular Hemispherical Shell System

The Initia T3 Acetabular Hemispherical Shell System is a cementless hip replacement socket made from titanium alloy (Ti-6Al-4V ELI) with a porous surface for bone fixation. It includes a polyethylene liner, bone screws, and a ceramic femoral head, and is indicated for patients with osteoarthritis, rheumatoid arthritis, hip fractures, and revision procedures.

The device uses identical indications for use, principle of operation, materials of manufacture, structural support mechanism, and range of sizes as its predicate devices. The primary predicate (K160895) is Kyocera's own Initia Total Hip System, and the additional predicate (K132312) is Renovis's Tesera T3 shell, which Kyocera acquired in 2019. Minor differences between subject and predicates do not raise new safety or effectiveness issues.

ISO 7206-12:2016 (shell rim and liner static testing), ASTM F3090-20 (shell fatigue), ASTM F1820-13 (shell-liner disassembly), ASTM F2582-20 (dynamic impingement with post-impingement loading), ISO 21535:2007 (range of motion), ISO 7206-10 (femoral head pull-off), ASTM F1877 (particulate analysis), and characterization of porous surface.

The subject device is substantially equivalent because it shares nearly identical technological characteristics with predicate devices including the same indications for use, operational principles, titanium and polyethylene materials, porous-coated uncemented design, and size ranges. Non-clinical testing demonstrates that the mechanical strength and performance of the Initia T3 system is sufficient for intended use and matches the performance profile of the legally marketed predicates.