Device Dossier
AMIStem C Cemented Stem - Uncoated hip femur prosthesis, modular
Device Dossier for AMIStem C Cemented Stem - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor Medacta).…
- GMDN category: Uncoated hip femur prosthesis, modular
Intended purpose
The AMIStem C hip prosthesis is designed for use in total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision hip surgery. Indications for use are: Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia, Avascular necrosis of the femoral head, Acute traumatic fracture of the femoral head or neck, Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty, Acute traumatic fracture of the femoral head or neck, Non-union of femoral neck fracture, Avascular necrosis of the femoral head, Primary pathology involving the femoral head but with a non deformed acetabulum.
Functional description
The AMIStem C is a cemented stem manufactured from high nitrogen stainless steel and has a mirrored polished surface. The stem has been developed to facilitate broaching and stem insertion when utilising the AMIS approach without compromising implant stability.