Device Dossier
HYDRA-FIX Cementless Stem Neck 12/14 - Coated hip femur prosthesis, modular
Device Dossier for HYDRA-FIX Cementless Stem Neck 12/14 - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor…
- GMDN category: Coated hip femur prosthesis, modular
Intended purpose
A sterile implantable femoral component of a total hip prosthesis designed to replace the femoral neck and stem. Indicated for; - Primary and secondary arthrosis - Rheumatoid and degenerative arthritis - Deformities, such as dysplasia - Fractures and necrosis of bone - Revisions, where other devices or treatments have failed - Metastatic diseases
Functional description
Forged Ti6Al4V alloy stem, HA coated at 80 microns. Proximally the stem has several transversal parallel grooves, while distally it has longitudinal ridges. This feature maximizes the bone/implant contact area and therefore improves prosthesis secondary fixation. Standard and Offset stems have the same CCD angle: 135°. The move from the standard to the offset option lateralizes the stem by 7.5mm but does not change the leg length.