Device Dossier

METS SMILES Knee, Tibial fixed hinge assembly - Uncoated knee tibia prosthesis, metallic

Device Dossier for METS SMILES Knee, Tibial fixed hinge assembly - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic,…

Intended purpose

The Tibial fixed hinge assembly is a component of the METS Smiles Total Knee Replacement which is intended for the replacement of diseased or deficient bone around the knee joint. Indications: • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis • Correction of varus, valgus or post traumatic deformity • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement • Ligament deficiencies • Tumor resections • Revision of previously failed total joint arthroplasty • Trauma • The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue.

Functional description

The SMILES Fixed Hinge assembly is a Co-Cr-Mo tibial component. Stem lengths 140 and 180mm and are available in small and standard sizes. An UHMWPE bumper available in both sizes provides a secondary bearing surface and a soft hyperextension stop, is pre-assembled within the tibial component.

TGA Public Summary