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..

915
Total
915
Cleared
135d
Avg days
1976
Since
915 devices
193–216 of 915
Cleared Jul 13, 2017
Unity Total Knee System
K170808
Corin U.S.A. Limited
Orthopedic · 118d
Cleared Jun 15, 2017
ATTUNE Cemented Tibial Base, Fixed Bearing
K170806
Depuy(Ireland)
Orthopedic · 90d
Cleared May 31, 2017
Empowr CR Knee Tibial Insert
K170573
Encore Medical, L.P.
Orthopedic · 93d
Cleared May 22, 2017
Smith & Nephew VISIONAIRE Adaptive Guides
K170282
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared May 11, 2017
ANTHEM CR Total Knee System
K170648
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Apr 28, 2017
Exactech® Truliant™ Line Extensions
K171045
Exactech, Inc.
Orthopedic · 21d
Cleared Apr 26, 2017
Apex Revision Knee System
K163332
Omnilife Science
Orthopedic · 149d
Cleared Mar 16, 2017
U2 Total Knee System E-XPE products
K161705
United Orthopedic Corporation
Orthopedic · 269d
Cleared Mar 06, 2017
GMK Sphere
K162035
Medacta International S.A.
Orthopedic · 227d
Cleared Mar 01, 2017
EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
K162026
Microport Orthopedics, Inc.
Orthopedic · 222d
Cleared Feb 23, 2017
Truliant Femoral Components
K170240
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 01, 2017
U2 Total Knee System, PSA Tibial Insert
K161360
United Orthopedic Corporation
Orthopedic · 261d
Cleared Jan 19, 2017
Anatomic Total Knee System
K161414
Amplitude
Orthopedic · 241d
Cleared Jan 13, 2017
Legion Cone System
K162775
Smith & Nephew, Inc.
Orthopedic · 102d
Cleared Dec 19, 2016
PS2 Knee System
K160515
Consensus Orthopedics, Inc.
Orthopedic · 299d
Cleared Dec 19, 2016
Destiknee Total Knee System
K160771
Meril Healthcare Private Limited
Orthopedic · 273d
Cleared Dec 01, 2016
LOSPA Modular Knee System
K160157
Corentec Co., Ltd.
Orthopedic · 314d
Cleared Nov 07, 2016
Materialise TKA Guide System
K162273
Materialise NV
Orthopedic · 87d
Cleared Oct 28, 2016
Klassic Knee System
K162422
Total Joint Orthopedics, Inc.
Orthopedic · 59d
Cleared Sep 23, 2016
EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)
K161945
Encore Medical, L.P.
Orthopedic · 70d
Cleared Sep 07, 2016
GENflex2 Total Knee System
K162222
Stelkast, Inc.
Orthopedic · 30d
Cleared Sep 06, 2016
Active-X Total Knee System
K160159
Signature Orthopaedics Pty, Ltd.
Orthopedic · 223d
Cleared Jul 15, 2016
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
K161668
Conformis, Inc.
Orthopedic · 29d
Cleared Jun 14, 2016
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
K161366
Conformis, Inc.
Orthopedic · 28d