Device Dossier

RinglocX E1 +3MM acetabular liner - Non-constrained polyethylene acetabular liner

Device Dossier for RinglocX E1 +3MM acetabular liner - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner,…

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 +3MM liner lateralises the femoral head by 3MM. 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 outer liner periphery engages with a floating metal ring located in the periphery of the metal shell component, providing a liner locking mechanism. Antioxidant infusion prevents oxidative polyethylene degradation. The +3MM liner lateralises the femoral head by 3MM as an alternative to a modular femoral head with longer neck.

TGA Public Summary