Device Dossier

Amistem-P Collared Cementless Stem 12/14 - Press-fit hip femur prosthesis, one-piece

Device Dossier for Amistem-P Collared Cementless Stem 12/14 - Press-fit hip femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece, Class…

Intended purpose

Device 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 surgery.

Functional description

AMIStem-P Collared is a straight triple tapered stem of rectangular cross-section manufactured from Ti-6Al-7Nb. The stem surface has horizontal and vertical macrostructures which increase the contact surface between stem and bone, improving implant stability. The proximal part of the stem is coated with a porous titanium layer and the whole stem body is coated with hydroxyapatite. The neck is mirror polished and the collar is designed to achieve the contact only with the medial femoral cortex.

TGA Public Summary