Device Dossier

R3 Constrained Liner - Constrained polyethylene acetabular liner

Device Dossier for R3 Constrained Liner - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner, Class III, sponsor Smith…

Intended purpose

The R3 Constrained Liner is an uncemented liner component of the R3 Constrained Liner Acetabular System intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Functional description

A sterile, ultrahigh molecular weight polyethylene (UHMWPE), cobalt-chrome (Co-Cr), titianium alloy (Ti6Al-4V) constrained liner which is a pre-assembled multi-piece component liner of a total hip consisting of a bipolar bearing which articulates with a captured outer polyethylene liner, locking ring and outer reinforcement ring. It allows for motion at two interfaces; the femoral head with the bipolar and the bipolar with the outer liner. The liner is impacted into an R3 acetabular shell.

TGA Public Summary