Device Dossier

EVOLUTION® Revision CCK Tibial Insert - Prosthesis, knee, internal, insert component

Device Dossier for EVOLUTION® Revision CCK Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

Intended purpose

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

Functional description

An UHMWPE tibial insert that is designed to mate with the EVOLUTION® Revision Tibial Base and to provide an articulating surface for the EVOLUTION® Revision CCK Femoral Component as part of a revision knee system. This device is used with a secondary locking screw through the tibial insert spine; it is indicated for revision scenarios, but is mainly used in cases where additional constraint is required. This device is available in sizes 1-8 standard and 2-6 plus options.

TGA Public Summary