Device Dossier

AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece

Device Dossier for AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece, Class III, sponsor…

Intended purpose

The AMIStem H hip prostheses are designed to be used in total or partial hip arthroplasty, for primary or revision surgery.

Functional description

The AMIStem-H has a triple tapered design that provides a good axial and rotational stability with optimal anchoring to the bone, and the rectangular section allows excellent stability and preservation of bone vascularisation. The horizontal and vertical macrostructures increase the stability and augment the contact surface area by 10-15%. The double tapered distal tip reduces the risk of stress peak in the diaphysis.

TGA Public Summary