# K202248: Attune Revision Sleeve LPS Femoral Adaptors

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Dec 28, 2020 after 140 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: 4 generations back to K870730 (1987). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071417: Depuy LPS Diaphyseal and Metaphyseal Sleeves, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K040281: LPS Metaphyseal Sleeve (Limb Preservation System), DePuy Orthopaedics, Inc. (2004) Summary page 4.

## Most influential descendants
- K253197: ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (2025), 0 descendants of its own

## Indications for use
The DePuy LPS System 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 System 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 sleeves are intended for either cemented or cementless applications.

Source page: https://510kreport.com/device/K202248
Methodology: https://510kreport.com/methodology