Z1 Hip System

The Z1 Hip System is a femoral hip stem designed for cementless total or hemi hip arthroplasty. It is indicated for joint wear from degenerative/post-traumatic/rheumatic diseases, failed previous hip surgery, acute femoral fractures, and avascular necrosis. The stem is made from titanium alloy with a grit-blasted surface, titanium plasma coating, and hydroxyapatite overcoat, offered in multiple sizes and neck lengths with various offset options.

The subject device has identical intended use, indications, design features, packaging, and sterilization to the predicate device. Raw materials are identical with modified processing. Both are titanium alloy femoral stems with wedge-shaped design, proximal-to-distal taper, and 12/14 male taper connection for compatibility with modular femoral heads.

ISO 7206-4 (Distal Fatigue Testing) and ISO 7206-6 (Proximal Fatigue Testing) were used to evaluate mechanical performance. Compatibility with femoral heads and range of motion were also evaluated.

Substantial equivalence is established because the subject device is identical to the predicate in intended use, indications for use, design features, materials (with only modified processing), packaging, and sterilization methods. Non-clinical fatigue testing per relevant ISO standards demonstrated the device performs equivalently to the predicate, and compatibility assessments confirmed proper function with previously cleared femoral heads.