# K041085: LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jul 22, 2004 after 87 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K870730 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003182: Orthogenesis LPS System, Depuy, Inc. (2001) Summary page 2.

## Recalls of this device
- Jul 11, 2013 · Class I · Z-1820-2013: The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.

## Indications for use
The LPS Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this system are the following: The 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., osteosarcoma, chondrosarcoma, 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 is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The distal femoral component, the tibial components, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.

Source page: https://510kreport.com/device/K041085
Methodology: https://510kreport.com/methodology