Device Dossier

Link Endo-Model EVO Condylar hinge knee tibial component - Rotating hinged total knee prosthesis

Device Dossier for Link Endo-Model EVO Condylar hinge knee tibial component - Rotating hinged total knee prosthesis (Rotating hinged total knee…

Intended purpose

The LINK Endo-Model EVO Knee System is a non-active, surgically-invasive, implantable device which is intended for long-term replacement of a diseased and/ or defective knee joint in the human body. It can be used with full-grown, anesthetized patients of any ethnic origin and sex. The LINK Endo-Model EVO Knee System is implanted with or without cement related to the selected implant version. The tibial component is generally indicated for use in mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. These include primary and secondary osteoarthritis; rheumatoid arthritis; revision after primary or revision total knee replacement, bone necrosis, varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers; oncological and revision surgery in lower limb (in conjunction with the Endo-Model W/ Endo-Model EVO-W and the Megasystem-C).

Functional description

The tibial component of the hinge version is manufactured from CoCrMo alloy. Three (3) sizes are available in widths ranging from 60 mm to 75 mm. The tibial components have also a modular taper connection for connection with modular stems. The Hinge Knee Prosthesis is linked by an axis mechanism.

TGA Public Summary