Device Dossier

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

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

Intended purpose

The SROM 11/13 Calcar Neck Femoral Stem is intended for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

Functional description

The SROM 11/13 Calcar Neck 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. The S-ROM 11/13 femoral stem is available with a variety of stem lengths, diameters, neck lengths and neck offsets.

TGA Public Summary