Device Dossier

METS, Short Tibial Bearing-MK4 - Rotating hinged total knee prosthesis

Device Dossier for METS, Short Tibial Bearing-MK4 - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor…

Intended purpose

The METS Short Tibial Bearing-MK4 is used in METS Distal Femoral Modular System, METS Proximal Tibial 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 previous joint replacement; Ligament deficiencies; Tumour resections; Revision of previously failed total joint arthroplasty; Trauma. METS Proximal Tibial Modular System is designed as a modular system that can be used to replace diseased or deficient bone in the proximal tibia. Indications: Primary bone tumour; Secondary tumour arising in bone; Non-neoplastic conditions affecting the shafts of long bones; Failed joint replacements with significant bone loss; Failed massive replacements. 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, METS Distal Femoral Modular System and METS Proximal Tibial Modular System.

TGA Public Summary