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
289–312 of 915
Cleared Oct 23, 2013
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
K131679
Wrightmedicaltechnologyinc
Orthopedic · 135d
Cleared Oct 11, 2013
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
K131337
Ortho Development Corp.
Orthopedic · 155d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
K132161
Exactech, Inc.
Orthopedic · 91d
Cleared Oct 08, 2013
APEX KNEE MODULAR TIBIA SYSTEM
K131472
Omni Life Science, Inc.
Orthopedic · 139d
Cleared Oct 03, 2013
NEO KNEE SYSTEM
K131368
Pipeline Orthopedics
Orthopedic · 143d
Cleared Sep 23, 2013
PIPELINE KNEE SYSTEM
K132046
Pipeline Orthopedics
Orthopedic · 83d
Cleared Sep 16, 2013
NOVOKNEE TOTAL KNEE SYSTEM
K131398
Novosource, Inc.
Orthopedic · 124d
Cleared Sep 13, 2013
CAS PSI KNEE SYSTEM
K131409
Orthosoft, Inc.
Orthopedic · 121d
Cleared Aug 22, 2013
GMK FULL PE TIBIAL COMPONENTS
K131310
Medacta International
Orthopedic · 107d
Cleared Aug 05, 2013
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
K122883
Stelkast Company
Orthopedic · 319d
Cleared Jul 26, 2013
GMK REVISION EXTENSION
K123721
Medacta International
Orthopedic · 234d
Cleared Jul 18, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K131467
Conformis, Inc.
Orthopedic · 58d
Cleared May 24, 2013
PIPELINE KNEE SYSTEM
K123692
Pipeline Orthopedics
Orthopedic · 172d
Cleared May 24, 2013
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
K131019
Conformis, Inc.
Orthopedic · 42d
Cleared May 03, 2013
NEO PS KNEE SYSTEM
K122500
Pipeline Orthopedics
Orthopedic · 260d
Cleared May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared May 03, 2013
MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM
K130084
Tgm Medical, Inc.
Orthopedic · 109d
Cleared Apr 15, 2013
LOSPA TOTAL KNEE REPLACEMENT SYSTEM
K130673
Corentec Co., Ltd.
Orthopedic · 34d
Cleared Apr 11, 2013
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING
K122239
Encore Medical, L.P.
Orthopedic · 258d
Cleared Apr 11, 2013
TK1 TOTAL KNEE SYSTEM
K123339
Novosource, Inc.
Orthopedic · 162d
Cleared Mar 22, 2013
BALANCED KNEE SYSTEM HIGH FLEX PS
K123457
Ortho Development Corp.
Orthopedic · 134d
Cleared Mar 20, 2013
OPTETRAK LOGIC POROUS FEMORAL COMPONENT
K123687
Exactech, Inc.
Orthopedic · 107d
Cleared Feb 22, 2013
PERSONA NATURAL TIBIA BASEPLATES
K130143
Zimmer, Inc.
Orthopedic · 31d
Cleared Feb 14, 2013
TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P
K123166
Howmedica Osteonics Corp.
Orthopedic · 128d