510(k) K240863

Freedom® Total Knee System by Maxx Orthopedics, Inc. — Product Code JWH

K240863 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Freedom® Total Knee System". The FDA issued a decision of Substantially Equivalent on July 2, 2024. 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. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2024
Date Received
March 28, 2024
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