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
217–240 of 915
Cleared Jun 10, 2016
ATTUNE Revision Knee System
K160700
Depuy(Ireland)
Orthopedic · 88d
Cleared May 19, 2016
EMPOWR PS Knee System
K160342
Encore Medical, L.P.
Orthopedic · 101d
Cleared Apr 12, 2016
All Poly Tibial Component
K152430
United Orthopedic Corporation
Orthopedic · 230d
Cleared Mar 25, 2016
Optetrak Logic Metaphyseal Cones
K153595
Exactech, Inc.
Orthopedic · 100d
Cleared Mar 25, 2016
iTotal Cruciate Retaining (CR) Knee Replacement System
K153721
Conformis, Inc.
Orthopedic · 88d
Cleared Mar 18, 2016
Optetrak Advanced Patella
K160484
Exactech, Inc.
Orthopedic · 25d
Cleared Mar 07, 2016
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
K160025
Conformis, Inc.
Orthopedic · 61d
Cleared Jan 07, 2016
ConforMIS iTotal Posterior Stabilized Knee Replacement System
K153217
Conformis, Inc.
Orthopedic · 63d
Cleared Dec 21, 2015
Apex Revision Knee System
K153437
Omnilife Science
Orthopedic · 24d
Cleared Dec 17, 2015
Klassic Knee System
K153310
Total Joint Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 25, 2015
Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
K152494
Zimmer, Inc.
Orthopedic · 85d
Cleared Nov 13, 2015
Klassic Knee System
K153075
Total Joint Orthopedics, Inc.
Orthopedic · 21d
Cleared Nov 12, 2015
Arthrex iBalance TKA System
K152382
Arthrex, Inc.
Orthopedic · 80d
Cleared Oct 29, 2015
Physica PS Knee System
K152008
Lima Corporate S.P.A.
Orthopedic · 100d
Cleared Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
K150241
Smith & Nephew, Inc.
Orthopedic · 267d
Cleared Oct 27, 2015
Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
K152169
Ortho Development Corporation
Orthopedic · 84d
Cleared Oct 21, 2015
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System
K152704
Conformis, Inc.
Orthopedic · 30d
Cleared Oct 21, 2015
JOURNEY II XR Knee System
K152726
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 06, 2015
Physica CR Knee System
K151266
Lima Corporate S.P.A.
Orthopedic · 146d
Cleared Sep 25, 2015
U2 Total Knee System- Additional Sizes
K150829
United Orthopedic Corporation
Orthopedic · 179d
Cleared Sep 03, 2015
Exactech Optetrak Logic Enhanced Assembly
K152170
Exactech, Inc.
Orthopedic · 30d
Cleared Aug 10, 2015
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
K150928
Materialise NV
Orthopedic · 126d
Cleared Jun 23, 2015
Progressive Orthopaedic Total Knee System
K150783
The Progressive Orthopaedic Company, LLC
Orthopedic · 90d
Cleared Jun 12, 2015
Total Knee Arthroplasty System
K150496
Responsive Orthopedics, LLC
Orthopedic · 107d