Device Dossier
TANDEM Unipolar Head - Metallic femoral head prosthesis
Device Dossier for TANDEM Unipolar Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Smith & Nephew). ARTG…
- GMDN category: Metallic femoral head prosthesis
- Sponsor: Smith & Nephew
Intended purpose
Smith & Nephew’s TANDEM Unipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty with a non-functional femoral head due to femoral neck fracture.
Functional description
A sterile cobalt chrome alloy (Co-Cr) femoral head intended to articulate against the natural acetabulum for partial hip replacement. It can be used with various stems to provide independent sizing of the acetabulum and femur. It is used with an appropriately sized taper sleeve to achieve proper joint restoration.