Device Dossier

METS Proximal Tibial Modular System, Integral Tibial Shaft & Stem, rotating hinge, coated - Knee stem

Device Dossier for METS Proximal Tibial Modular System, Integral Tibial Shaft & Stem, rotating hinge, coated - Knee stem (Knee stem, Class III, sponsor…

Intended purpose

The Proximal Tibial Modular System, Integral Tibial Shaft & Stem, rotating hinge, coated is a component of the METS Proximal Tibial Modular System which is designed as a modular system that can be used to replace diseased or deficient bone in the proximal tibia. The indications for this modular massive endoprosthetic system are: • Primary bone tumours • Secondary tumours arising in bone • Non-neoplastic conditions affecting the shafts of long bones • Failed joint replacements • Failed massive replacements

Functional description

The Integral Tibial Shaft & Stem, rotating hinge is a 55mm long titanium shaft with integral HA collar and stem components for the rotating hinged proximal tibial replacement. It is used for short resections < 120mm and has a 120mm straight tibial stem and diameter 10mm. Insert the integral shaft/stem construct into the proximal component ensuring that the alignment lug is correctly engaged. Impact with the soft ended hammer provided to lock the taper securely in place. For Cemented use only.

TGA Public Summary