ceramys™ femoral head system

The ceramys™ femoral head system is a ceramic prosthetic femoral head used in hip replacement surgery. It is indicated for patients with degenerative joint disease, rheumatoid arthritis, femoral fracture, or functional deformity who require total hip arthroplasty or revision surgery. The device consists of alumina toughened zirconia ceramic heads and titanium adapter sleeves available in multiple sizes (28–44 mm diameter) and offset options.

The ceramys™ femoral head system and predicate BIOLOX® delta ceramic heads are offered in the same diameters and offsets, but the subject device uses a different ceramic material formulation. Both are ceramic femoral heads with titanium sleeves that attach to femoral stems via 12/14 taper connections; the key difference is the specific ceramic composition.

Testing followed ISO standards (ISO 7206-10, ISO 13356, ISO 22214, ISO 14705, ISO 13383-1, ISO 14242-1, ISO 23146, ISO 11491) and ASTM standards (ASTM C674-13, ASTM F1875-14, ASTM F3143-20, ASTM F2052-21, ASTM F2345-21) covering material composition, mechanical properties, fatigue, wear, corrosion, and MRI compatibility.

Although the ceramys™ device uses a different ceramic formulation than the BIOLOX® delta predicate, comparative performance testing demonstrates that both devices provide the same functionality and are substantially equivalent. Both share identical intended use, same size and offset offerings, and same surgical application pathway; the material formulation difference is supported by biocompatibility testing and comprehensive performance testing across mechanical, wear, corrosion, and safety parameters that show equivalence.