Device Dossier

S-ROM SPA Proximal Sleeve - Coated hip femur prosthesis, modular

Device Dossier for S-ROM SPA Proximal Sleeve - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor DePuy…

Intended purpose

The S-ROM SPA Proximal Sleeves are used with the S-ROM femoral stem to help achieve proximal fill. The components of the S-ROM Total Hip System are indicated 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 S-ROM SPA Proximal Sleeves are made out of Titanium and are porous coated for cementless use only. The S-ROM SPA Proximal Sleeves are used with the S-ROM femoral stem to help achieve proximal fill during hip arthroplasty.

TGA Public Summary