Device Dossier

METS, Long Poly Tibial Bearing - Rotating hinged total knee prosthesis

Device Dossier for METS, Long Poly Tibial Bearing - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor…

Intended purpose

The long tibial bearing is used in METS Distal Femoral Modular System and METS SMILES Total Knee Replacement. The METS Distal Femoral Modular System is designed as a modular system that can be used to replace diseased or deficient bone in the distal femur. Indications: Limb salvage procedures where radical resection and replacement of the bone is required; 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 previousjoint replacement; Ligament deficiencies; Tumour resections; Revision of previously failed total joint arthroplasty; Trauma. The METS SMILES TKR is designed as a modular system that can be used to replace diseased or deficient bone around the knee joint. Indications: Gross knee instability; Unusual anatomy; Failed primary knee replacements; Complex revision arthroplasty.

Functional description

A UHMWPE tibial bearing to be used as part of the articulating surfaces of the Rotating Hinge Polyethylene Tibia variation of the METS SMILES TKR and METS Distal Femoral Modular System

TGA Public Summary