Device Dossier

Cross-Linked PE Insert - Acetabulum prosthesis

Device Dossier for Cross-Linked PE Insert - Acetabulum prosthesis (Acetabulum prosthesis, Class III, sponsor Adler Ortho). ARTG record, intended purpose,…

Intended purpose

The cross-linked PE/PE insert is designed to be used in total hip arthroplasty (THA), as an articulating surface, and to interface with a ceramic femoral head or a Co-Cr femoral head, after insertion into an acetabulum prosthesis shell (acetabular cup).

Functional description

The cross-linked PE/PE insert is fitted into the acetabular cup (acetabular shell) and is blocked inside the cup through a locking system present of the acetabular cup in the same group size with which the insert is coupled (i.e. equatorial teeth). It is available in different internal diameters and it articulates with the ceramic femoral head or the Co-Cr femoral head of the same internal diameter of the insert, permitting to restore the physiological motion of the hip joint.

TGA Public Summary