510(k) K262130

ATTUNE Revision Knee System by Depuy Orthopaedics, Inc. — Product Code JWH

K262130 is an FDA 510(k) premarket notification submitted by Depuy Orthopaedics, Inc. for the device "ATTUNE Revision Knee System". The FDA issued a decision of Substantially Equivalent on September 4, 2026. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Depuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2026
Date Received
June 24, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type