Device Dossier
Avenir Complete™ Hip System - Coated hip femur prosthesis, modular
Device Dossier for Avenir Complete™ Hip System - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Zimmer…
- GMDN category: Coated hip femur prosthesis, modular
Intended purpose
These devices are intended for total hip arthroplasty for primary procedures. Indications: The Avenir Complete Hip System is indicated for total hip arthroplasty with cementless applications in the following conditions: • Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases • Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists • Avascular necrosis of the femoral head • Acute traumatic fracture of the femoral head or neck
Functional description
The Avenir Complete Hip System is a femoral stem component intended for long-term cementless fixation into the proximal femur of patients with adequate bone stock. The proximal end consists of a 12/14 taper, designed to mate with the corresponding femoral head component, and to be compatible with the Zimmer Biomet modular 12/14 taper femoral heads in total hip arthroplasty.