Device Dossier
METS Proximal Tibial Modular System, Integral Tibial Shaft & Stem, fixed hinge, HA coated - Knee stem
Device Dossier for METS Proximal Tibial Modular System, Integral Tibial Shaft & Stem, fixed hinge, HA coated - Knee stem (Knee stem, Class III, sponsor…
Intended purpose
The Integral Tibial Shaft & Stem, fixed 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, fixed hinge, coated is a 15mm long titanium shaft, diameter 33mm, with integral hydroxyapatite collar and stem components for the fixed hinged proximal tibial replacement. Holding the proximal tibial component with the bore pointing upwards, insert the integral shaft/stem construct ensuring that the alignment lug is correctly engaged. Apply multiple sharp blows using the soft ended hammer provided to lock the taper securely in place. For Cemented use only.