Device Dossier

S-ROM M-Spec Femoral Metal Head - Metallic femoral head prosthesis

Device Dossier for S-ROM M-Spec Femoral Metal Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor DePuy…

Intended purpose

The S-ROM M-Spec Metal Femoral Head is one component of total hip arthroplasty which is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

Functional description

The S-ROM M-Spec Metal Femoral Head is made of cobalt chrome and fixes onto an 11/13 tapered femoral stem implant. It articulates with a polyethylene acetabular liner.

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