ATTUNE Total Knee System; ATTUNE Cementless Knee System— 510(k) K261458
Substantially EquivalentDePuy Ireland UC
FDA 510(k) clearance K261458 for ATTUNE Total Knee System; ATTUNE Cementless Knee System, Substantially Equivalent on 2026-06-25. Applicant: DePuy Ireland UC. Device class: 2.
Summary
DePuy Ireland's clearance names two systems, the ATTUNE Total Knee System and the ATTUNE Cementless Knee System. The record lists one product code for both, JWH, semi-constrained, cemented patellofemorotibial knee prostheses of polymer/metal/polymer construction. The second name says cementless while the code name says cemented, and the record doesn't explain the difference.
Class II, 21 CFR 888.3560. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
DePuy filed from Cork, Ireland. The decision came 55 calendar days after receipt (May 1 to June 25, 2026).
Clearance details
- Applicant
- DePuy Ireland UC
- Product code
- Product code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cork, IE
Recent devices under product code JWH
view allMore clearances from DePuy Ireland UC
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.