Device Dossier

LPS Universal Tibial Hinge Insert - Rotating hinged total knee prosthesis

Device Dossier for LPS Universal Tibial Hinge Insert - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor…

Intended purpose

The LPS Universal Tibial Hinge Insert is the bearing component of the LPS System which is intended for use in cases that require extensive resection and replacement. Specific diagnostic indications for use include: • malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; • patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; • revision cases for a failed previous prosthesis requiring extensive resection and replacement; • severe trauma requiring extensive resection and replacement. The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

Functional description

The LPS Univesal Tibial Hinge Insert is made of polyethylene with a CoCr core hinge which connects to the LPS Distal Femur or the S-ROM femoral rotating hinge femoral component. The LPS Universal Tibial Hinge Insert articulates on an appropriate tibial tray.

TGA Public Summary