510(k) K193540

TRUMATCH Personalized Solutions by DePuy Orthopaedics, Inc. — Product Code JWH

K193540 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "TRUMATCH Personalized Solutions". The FDA issued a decision of Substantially Equivalent on June 16, 2020. 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
June 16, 2020
Date Received
December 20, 2019
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