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..

914
Total
914
Cleared
135d
Avg days
1976
Since
914 devices
193–216 of 914
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 13, 2017
Legion Cone System
K162775
Smith & Nephew, Inc.
Orthopedic · 102d
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 Sep 23, 2016
EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)
K161945
Encore Medical, L.P.
Orthopedic · 70d
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
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 Nov 25, 2015
Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
K152494
Zimmer, Inc.
Orthopedic · 85d
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 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