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
217–240 of 911
Cleared Jan 10, 2013
OPTETRAK LOGIC CRC TIBIAL INSERT
K123342
Exactech, Inc.
Orthopedic · 71d
Cleared Nov 09, 2012
PERSONA NATURAL TIBIA BASEPLATES
K122765
Zimmer, Inc.
Orthopedic · 60d
Cleared Aug 13, 2012
JOURNEY II CR KNEE SYSTEM
K121443
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 31, 2012
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ
K121307
Exactech, Inc.
Orthopedic · 30d
Cleared May 18, 2012
GENESIS II PS NON-MODULAR FEMORAL COMPONENT
K120698
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Mar 27, 2012
ZIMMER PERSONA KNEE SYSTEM
K113369
Zimmer, Inc.
Orthopedic · 133d
Cleared Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
K113482
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
K112941
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 09, 2011
EVOLUTION MP ADAPTIVE CS INSERT
K113325
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Sep 16, 2011
JOURNEY II BCS KNEE SYSTEM
K111711
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Aug 16, 2011
TRUMATCH PERSONALIZED SOLUTIONS
K110397
DePuy Orthopaedics, Inc.
Orthopedic · 186d
Cleared Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K111400
Exactech, Inc.
Orthopedic · 70d
Cleared Apr 22, 2011
REVISION PROTHESIS
K110837
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Mar 24, 2011
GMK REVISION KNEE SC LINERS
K103170
Medacta International S.A.
Orthopedic · 148d
Cleared Feb 23, 2011
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
K102125
Biomet, Inc.
Orthopedic · 209d
Cleared Jan 07, 2011
EVOLUTION MP TOTAL KNEE SYSTEM
K102380
Wrightmedicaltechnologyinc
Orthopedic · 137d
Cleared Oct 22, 2010
VANGUARD 360 REVISION KNEE SYSTEM
K093293
Biomet, Inc.
Orthopedic · 366d
Cleared Sep 29, 2010
DEPUY UNIVERSAL GRIPTION TF CONES
K100391
DePuy Orthopaedics, Inc.
Orthopedic · 225d
Cleared Sep 24, 2010
GMK REVISION KNEE SYSTEM
K102437
Medacta International S.A.
Orthopedic · 29d
Cleared Aug 26, 2010
JOURNEY CR KNEE SYSTEM
K101499
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Aug 02, 2010
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
K101981
Exactech, Inc.
Orthopedic · 19d
Cleared Apr 14, 2010
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
K093746
Smith & Nephew, Inc.
Orthopedic · 131d
Cleared Apr 08, 2010
MYKNEE CUTTING BLOCKS
K093806
Medacta International S.A.
Orthopedic · 118d
Cleared Mar 04, 2010
EVOLUTION MP TOTAL KNEE SYSTEM
K093552
Wrightmedicaltechnologyinc
Orthopedic · 107d