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,…
- GMDN category: Rotating hinged total knee prosthesis
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.