K261458
- 510(k) number
- K261458
- Device name
- ATTUNE Total Knee System; ATTUNE Cementless Knee System
- Applicant
- DePuy Ireland UC IE
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2026-06-25
- Date received
- 2026-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261458.pdf
Official FDA record: K261458
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.