CATALYSTEM Femoral Stems

The CATALYSTEM Femoral Stems are uncemented femoral stem implants for primary hip arthroplasty in skeletal mature patients. They are indicated for total and partial hip replacement in patients with degenerative joint disease, avascular necrosis, traumatic arthritis, inflammatory degenerative joint disease, and certain fractures where other treatments have failed.

The CATALYSTEM Femoral Stems are identical in design, function, materials, intended use, and indications to the predicate device CATALYSTEM Femoral Stems (K240381). The only difference is the addition of femoral head compatibility, allowing use with additional Smith & Nephew femoral heads and acetabular components.

Neck fatigue testing per ISO 7206-6; engineering analysis for distal stem fatigue (ISO 7206-4:2010); range of motion analysis (ISO 21535:2023); impingement analysis (ASTM F2582-20).

Substantial equivalence is established because the subject device has identical technological characteristics, design, function, and materials to the predicate K240381, with only the addition of femoral head compatibility options. Bench testing demonstrates the subject device meets required acceptance criteria with no additional risks compared to the predicate, and clinical use indications are identical.