Device Dossier
METS Proximal Tibial Modular System, Tibial Component, Rotating Hinge with bumper - Uncoated knee tibia prosthesis, metallic
Device Dossier for METS Proximal Tibial Modular System, Tibial Component, Rotating Hinge with bumper - Uncoated knee tibia prosthesis, metallic (Uncoated…
- GMDN category: Uncoated knee tibia prosthesis, metallic
- Sponsor: Stryker
Intended purpose
The Tibial component, Rotating Hinge with bumper is a component of the METS proximal tibial replacement 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 Tibial Component, Rotating Hinge with bumper is a CoCrMo rotating hinged tibial component intended for use with the proximal tibial rotating hinge. A UHMWPE bumper pad provides a secondary bearing surface and a soft hyperextension stop. The proximal tibial component is inserted into the tibial canal and cemented securely into place, ensuring correct rotational alignment. The rotating hinge tibial component is then inserted into the rotating hinge proximal tibial component.