Device Dossier
Symbol Delta Ceramic Liner - Ceramic acetabular liner
Device Dossier for Symbol Delta Ceramic Liner - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Active Surgical). ARTG record,…
- GMDN category: Ceramic acetabular liner
Intended purpose
The Device is a permanent prosthetic replacement of the acetabular component of the hip joint, during first-line total hip arthroplasty in the adult population. STATED CLINICAL PERFORMANCES are Functional recovery, Joint function restored, Pain relief, Life-span of implants 10 years. The INDICATIONS are Destruction of the hip joint, resulting from degenerative, post-traumatic or inflammatory damage and Femoral head fracture or avascular necrosis.
Functional description
The device is the acetabular component of a total hip prosthesis made from biolox delta ceramic. It provides the articulating surface for the acetabulum prosthesis, after insertion into an acetabulum prosthesis shell, to interface with a femoral head prosthesis as part of a total hip replacement. The liner is packaged with a gripper allowing its impaction in the cup using a specific tip. The femoral head is reduced in the liner