Alteon® HA Femoral Stems

The Alteon HA Femoral Stems are hip replacement components intended for press-fit fixation in skeletally mature patients undergoing primary hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic hip problems, or proximal femoral fractures. The stems are manufactured from titanium alloy (Ti-6Al-4V ELI) with a grit-blasted surface and hydroxyapatite coating, available in multiple lengths and configurations with trapezoidal geometry and grooves for bone engagement.

The subject device is identical to the predicate device in all respects except for the hydroxyapatite (HA) coating material and process applied to the stem surface. Both devices use the same Ti-6Al-4V ELI base material, identical design geometry, dimensions, configurations (collared/collarless, standard/extended neck offset), and are compatible with the same femoral heads and acetabular components. Both are provided sterile for single use and conform to the same performance standards.

ISO 21535:2007 (range of motion), ASTM F2068-2015 (fatigue testing), ISO 7206-6:2013 (stem neck fatigue), ISO 7206-4:2010 (distal stem fatigue), ISO 13779-2 (HA coating characterization), FDA Guidance on 510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants (February 1997), USP <161> and <85> (bacterial endotoxins), and ANSI/AAMI ST72.

The subject device differs from the predicate only in the applied HA coating material and process, while maintaining identical indications for use, base materials, design features, dimensions, and compatibility with existing component systems. Non-clinical testing demonstrates that this coating difference does not adversely affect safety, performance, or effectiveness—range of motion, fatigue resistance, coating characterization, and biocompatibility all support that the HA coating does not change the fundamental functional performance or safety profile compared to the predicate device.