Device Dossier

Ringloc-X E1 acetabular liner - Non-constrained polyethylene acetabular liner

Device Dossier for Ringloc-X E1 acetabular liner - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class…

Intended purpose

Alpha-tocopherol infused highly cross linked ultra high molecular weight polyethylene acetabular liner, for use as one component of a total hip joint replacement system. The indications for use of acetabular liners as part of a joint replacement system include: Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and post-traumatic arthritis; rheumatoid arthritis; correction of functional deformity; revision of failed joint reconstruction or treatment; treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques.

Functional description

Vitamin E infused highly cross linked UHMWPE Ringloc-X acetabular liner for use with an Exceed Ringloc-X acetabular shell. A groove around the other periphery of the liner is intended to engage with a floating metal ring located in the periphery of the metal shell component, providing a liner locking mechanism. Antioxidant infusion is intended to prevent oxidative degradation of the polyethylene.

TGA Public Summary