Device Dossier

LPS XX-SM Distal Femoral Poly Bumper - Rotating hinged total knee prosthesis

Device Dossier for LPS XX-SM Distal Femoral Poly Bumper - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III,…

Intended purpose

The LPS poly bumper is one component of the LPS Limb Preservation System which is indicated for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially 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

A polyethyelene bumper that acts a physical stop to prevent excessive motion of the LPS Femoral component.

TGA Public Summary