# K242665: DePuy ATTUNE™ Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Orthopedics, Inc.
- Decided: Nov 1, 2024 after 58 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103756: Depuy Attune Total Knee System, DePuy Orthopaedics, Inc. (2011) Summary page 6.
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 6.

## Indications for use
The DePuy Attune Total 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/K242665
Methodology: https://510kreport.com/methodology