Device Dossier

S-ROM 11/13 Standard Femoral Stem - Press-fit hip femur prosthesis, modular

Device Dossier for S-ROM 11/13 Standard Femoral Stem - Press-fit hip femur prosthesis, modular (Press-fit hip femur prosthesis, modular, Class III,…

Intended purpose

The S-ROM 11/13 Standard Femoral Stem is intended for use in total hip arthroplasty procedures to replace the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Functional description

The S-ROM 11/13 Standard Femoral Stem is made of titanium alloy and accepts a 11/13 tapered femoral head. The S-ROM 11/13 Femoral Stem is uncoated and fixation is achieved by using a proximal sleeve whose outer surface is porous-coated to promote bony ingrowth. It has a variety of neck lengths, a standard neck design and a standard neck design with increased offsets.

TGA Public Summary