Device Dossier
TANDEM Unipolar 12/14 Taper Sleeve - Metallic femoral head prosthesis
Device Dossier for TANDEM Unipolar 12/14 Taper Sleeve - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Smith &…
- 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, titanium alloy (Ti-6Al-4V) sleeve with a 12/14 taper used with the TANDEM Unipolar Head for partial hip replacement. The sleeve is provided in five neck lengths to achieve proper joint restoration.