Device Dossier

Unity Knee CR Insert - Cruciate-retaining total knee prosthesis

Device Dossier for Unity Knee CR Insert - Cruciate-retaining total knee prosthesis (Cruciate-retaining total knee prosthesis, Class III, sponsor Corin).…

Intended purpose

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of suffiecent sound bone to seat and support the components.

Functional description

The Unity Knee™ is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee™ CR is intended for use in instances where the posterior cruciate ligament (PCL) is functional. The Unity Knee™ is intended for cemented use, single use only.

TGA Public Summary