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
193–216 of 911
Cleared Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
K150241
Smith & Nephew, Inc.
Orthopedic · 267d
Cleared Oct 21, 2015
JOURNEY II XR Knee System
K152726
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 03, 2015
Exactech Optetrak Logic Enhanced Assembly
K152170
Exactech, Inc.
Orthopedic · 30d
Cleared May 29, 2015
Exactech Optetrak Logic CC
K150890
Exactech, Inc.
Orthopedic · 57d
Cleared Feb 12, 2015
Vanguard 360 Revision Knee System
K143192
Biomet, Inc.
Orthopedic · 98d
Cleared Feb 12, 2015
Visionaire Disposable Instruments
K143226
Smith & Nephew, Inc.
Orthopedic · 94d
Cleared Dec 23, 2014
Biomet Tibial trays
K142933
Biomet, Inc.
Orthopedic · 75d
Cleared Dec 22, 2014
Zimmer Persona Personalized Knee System
K142787
Zimmer, Inc.
Orthopedic · 87d
Cleared Dec 22, 2014
ANTHEM PS Total Knee System
K142807
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 19, 2014
Arthrex iBalance Patella Implant, Dome
K143047
Arthrex, Inc.
Orthopedic · 27d
Cleared Nov 14, 2014
JOURNEY II XR KNEE SYSTEM
K141471
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Aug 21, 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
K141585
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Jul 03, 2014
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
K140902
Biomet, Inc.
Orthopedic · 85d
Cleared May 29, 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 27, 2014
ARTHREX IBALANCE TKA SYSTEM
K133854
Arthrex, Inc.
Orthopedic · 70d
Cleared Feb 04, 2014
ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
K133737
Zimmer, Inc.
Orthopedic · 57d
Cleared Dec 17, 2013
ARTHREX IBALANCE TKA SYSTEM
K133342
Arthrex, Inc.
Orthopedic · 48d
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708
Smith & Nephew, Inc.
Orthopedic · 271d
Cleared Oct 23, 2013
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
K131679
Wrightmedicaltechnologyinc
Orthopedic · 135d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
K132161
Exactech, Inc.
Orthopedic · 91d
Cleared May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159
Smith & Nephew, Inc.
Orthopedic · 206d
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