# K262130: ATTUNE Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Orthopaedics, Inc.
- Decided: Sep 4, 2026 after 72 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: 6 generations back to K943462 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160700: ATTUNE Revision Knee System, Depuy (Ireland) (2016) Summary page 6.

## Indications for use
Candidates for total knee replacement include patients with • A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis • Moderate valgus, varus, or flexion deformities • Avascular necrosis of the femoral condyle • A previous unsuccessful knee replacement, osteotomy, or other knee procedure ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with: • Absence or loss of both cruciate ligaments • Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon • Bone loss that requires supplemental fixation in the clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications. ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K262130
Methodology: https://510kreport.com/methodology