# K253197: ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Nov 19, 2025 after 54 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: 12 generations back to K810258 (1981). 91 ancestors in all.
No later device cites it as a predicate yet.
1 of 92 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211609: ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert, Depuy Ireland UC (2021) Summary page 7.
- K202248: Attune Revision Sleeve LPS Femoral Adaptors, Depuy Ireland UC (2020) Summary page 9.

## Indications for use
ATTUNE™ Total Knee System Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors 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/K253197
Methodology: https://510kreport.com/methodology