Device Dossier

Evolution Stemmed Femoral CS - Uncoated knee femur prosthesis

Device Dossier for Evolution Stemmed Femoral CS - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor MicroPort…

Intended purpose

A total knee system component used to replace the distal femur. Indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions: 1. revision procedures where other treatments or devices have failed.

Functional description

The EVOLUTION® stemmed CS femoral component is designed to be used in total knee arthroplasty (TKA). It is made of CoCr alloy and is compatible with the existing optional stem extensions, femoral offset adapters, stem adapters, and femoral augments in the EVOLUTION® revision knee system. In conjunction with the EVOLUTION® medial pivot (MP) CS insert, the Device provides stemmed medial pivot articulation that provides a level of constraint sufficient for posterior cruciate ligament substitution.

TGA Public Summary