# K040281: LPS Metaphyseal Sleeve (Limb Preservation System)

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 9, 2004 after 154 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: none
- 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.
54 later devices descend from it; 4 cite it directly.
1 of 64 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 3.
- K870730: Noiles Total Knee Prosthesis, Joint Medical Products Corp. (1987) Summary page 3.

## Most influential descendants
- K060515: Depuy PFC Sigma Knee Prosthesis (2006), 36 descendants of its own
- K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves (2007), 31 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K162422: Klassic Knee System (2016), 23 descendants of its own
- K180159: Klassic® Knee System (2018), 22 descendants of its own

## Indications for use
The metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The metaphyseal sleeve is intended for use in primary and revision knee joint replacement and in oncology cases across several product lines: the Limb Preservation System (LPS), the S-ROM Modular Knee system, and the P.F.C. Sigma system. The previously cleared indications for use for these systems 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., 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 is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The metaphyseal sleeve, the distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only. The S-ROM Modular Total Knee System was cleared as the "NOILES Posterior Stabilized Knee." The NOILES Posterior Stabilized Knee is indicated for use with PMMA bone cement in primary or revised cases in patients: * who have reached skeletal maturity and * for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate ligaments are absent or incompetent due to the following conditions: rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma. The P.F.C.® Sigma Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout. This damage may also be a result of trauma or failed prior surgical intervention. The P.F.C.® Sigma Knee System is indicated for use with polymethylmethacrylate (PMMA) bone cement.

Source page: https://510kreport.com/device/K040281
Methodology: https://510kreport.com/methodology