JWH · Class II · 21 CFR 888.3560

FDA Product Code JWH: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Total knee replacement is one of the most common orthopedic procedures in the United States. FDA product code JWH covers semi-constrained patellofemorotibial knee prostheses — implants that replace the articular surfaces of the femur, tibia, and patella to restore pain-free mobility.

These systems are designed to replicate the biomechanics of the natural knee while providing long-term stability. They are used in patients with advanced osteoarthritis, rheumatoid arthritis, or post-traumatic joint damage.

JWH devices are Class II medical devices, regulated under 21 CFR 888.3560 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Zimmer, Inc., Smith & Nephew, Inc. and Howmedica Corp..

911
Total
911
Cleared
135d
Avg days
1976
Since
911 devices
97–120 of 911
Cleared May 05, 2021
Genius / Genuin Total Knee System
K200765
Biorad Medisys Pvt, Ltd.
Orthopedic · 407d
Cleared Apr 21, 2021
MOBIO Total Knee System
K210483
B-One Ortho, Corp.
Orthopedic · 61d
Cleared Apr 21, 2021
U2 Total Knee System, XPE Tibial Insert, PS PLUS
K210961
United Orthopedic Corporation
Orthopedic · 21d
Cleared Apr 02, 2021
Apex Knee System
K201611
Omnilife Science
Orthopedic · 291d
Cleared Mar 18, 2021
Persona Revision Knee System
K210551
Zimmer, Inc.
Orthopedic · 21d
Cleared Feb 17, 2021
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
K210252
Conformis, Inc.
Orthopedic · 19d
Cleared Dec 28, 2020
Attune Revision Sleeve LPS Femoral Adaptors
K202248
Depuy Ireland UC
Orthopedic · 140d
Cleared Dec 22, 2020
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
K203447
Conformis, Inc.
Orthopedic · 29d
Cleared Dec 11, 2020
GMK Total Knee System - TiNbN Coating
K202684
Medacta International S.A.
Orthopedic · 87d
Cleared Nov 18, 2020
Freedom(R) - TiNbN Coated Knee
K200912
Maxx Orthopedics, Inc.
Orthopedic · 226d
Cleared Oct 23, 2020
Mobio Total Knee System
K202429
B-One Ortho, Corp.
Orthopedic · 59d
Cleared Oct 09, 2020
Klassic Knee System Tibial Inserts, PS-Max
K202740
Total Joint Orthopedics, Inc.
Orthopedic · 21d
Cleared Sep 18, 2020
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)
K202022
Medacta International S.A.
Orthopedic · 58d
Cleared Jul 30, 2020
EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
K201851
Corentec Co., Ltd.
Orthopedic · 24d
Cleared Jul 10, 2020
Triathlon Total KneeSystem
K201343
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 51d
Cleared Jun 16, 2020
TRUMATCH Personalized Solutions
K193540
DePuy Orthopaedics, Inc.
Orthopedic · 179d
Cleared Jun 16, 2020
iTotal® Identity Posterior Stabilized Knee Replacement System
K201023
Conformis, Inc.
Orthopedic · 57d
Cleared Jun 04, 2020
Journey II XR Knee Instrument
K200227
Smith & Nephew, Inc.
Orthopedic · 126d
Cleared May 07, 2020
LOSPA II Knee System (EXULT Knee Replacement System)
K200395
Corentec Co., Ltd.
Orthopedic · 79d
Cleared May 07, 2020
AMF Revision TT Cones
K200653
Lima Corporate S.P.A.
Orthopedic · 56d
Cleared Apr 24, 2020
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
K200826
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Mar 24, 2020
Persona Personalized Knee System
K200209
Zimmer, Inc.
Orthopedic · 56d
Cleared Mar 13, 2020
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
K193105
Conformis, Inc.
Orthopedic · 126d
Cleared Mar 13, 2020
3DMetal Diaphyseal Femoral Cones
K200075
Medacta International S.A.
Orthopedic · 59d