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…
- GMDN category: Constrained polyethylene acetabular liner
- Sponsor: Smith & Nephew
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.