Device Dossier

Logical Constrained XLPE Acetabular Liner - Constrained polyethylene acetabular liner

Device Dossier for Logical Constrained XLPE Acetabular Liner - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner,…

Intended purpose

The Logical Constrained XLPE Acetabular Liner is intended to be used in hip joint replacement where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: -Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis -Inflammatory joint disease including rheumatoid arthritis (excluding TSI stem) -Correction of functional deformity including congenital hip dysplasia -Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture -Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Functional description

The Logical Constrained Liner connects to an acetabular shell and provides an articular surface for a femoral head as part of a total hip joint replacement. The device includes a mechanism for retaining the femoral head within the liner to prevent dislocation. The device is manufactured from cross-linked polyethylene and incorporates a snap-ring manufactured from Ti6Al4V alloy.

TGA Public Summary