K253197
- 510(k) number
- K253197
- Device name
- ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
- Applicant
- Depuy Ireland UC IE
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2025-11-19
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K253197.pdf
Official FDA record: K253197
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.