# K252887: DePuy ATTUNE™ Knee System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 22, 2026 after 254 days
- Product code: OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive)
- 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: 5 generations back to K943462 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 6.
- K111433: Depuy Sttune (TM) PS Knee System, DePuy Orthopaedics, Inc. (2011) Summary page 6.

## Indications for use
The DePuy ATTUNE Knee System is intended for use as a total knee replacement 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.

Source page: https://510kreport.com/device/K252887
Methodology: https://510kreport.com/methodology