Device Dossier
Unity Knee CS Tibial insert - Prosthesis, knee, internal, insert component
Device Dossier for Unity Knee CS Tibial insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The Unity Knee™ 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 sufficient sound bone to seat and support the components. The Unity Knee CS Tibial insert is designed to securely fix with the locking mechanism on the Unity Knee™ tibial tray and is compatible with the Unity Knee™ CR Femoral Component only. The condylar stabilized (CS) fixed tibial insert is intended to be implanted in knee joints, where there is a deficiency on the posterior cruciate ligament (PCL) or where the PCL is absent.
Functional description
The Unity Knee CS Tibial insert is designed to securely fix with the locking mechanism on the Unity Knee™ tibial tray and is compatible with the Unity Knee™ CR Femoral Component only. The condylar stabilized (CS) fixed tibial insert is intended to be implanted in knee joints, where there is a PCL deficiency or where the PCL is absent. It is made from UHMWPE and features a raised anterior lip, deep tibial condyles and a raised central tibial ridge and is intended for cemented use,single use only.