Device Dossier
G7 Vivacit-E Freedom Constrained Liners - Constrained polyethylene acetabular liner
Device Dossier for G7 Vivacit-E Freedom Constrained Liners - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner, Class…
- GMDN category: Constrained polyethylene acetabular liner
Intended purpose
The G7 Vivacit‑E Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Functional description
Infused with Vitamin E which acts to maximize polyethylene strength, wear resistance and oxidative resistance, the liners are preassembled with a constraining ring around the opening, designed to increase resistance to femoral head lever-out under high demand conditions. Intended to mate with a compatible femoral head containing a circumferential flat, which allows for joint reduction; and a compatible acetabular shell secured by engaging the polyethylene barb and groove locking mechanism.