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The DePuv LPS is intended 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 ioint 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. .

It is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

The porous-coated metaphyseal and diaphyseal sleeves are intended for either cemented or cementless applications.

The technological characteristics of the DePuy LPS Universal Technological Hinge Insert Assembly are similar to the predicate devices Characteristics: including design, performance and material type.

This is a 510(k) summary for a medical device (DePuy LPS Universal Hinge Insert Assembly) and does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document discusses:

• The device's intended use and classification.
• Its substantial equivalence to predicate devices based on design, performance, and material type, as demonstrated by pre-clinical data (not clinical study data).
• The FDA's decision to clear the device for market.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment. The provided text is a regulatory filing, not a scientific study report.

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