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
289–312 of 914
Cleared Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
K113482
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Feb 16, 2012
EAUM TOTAL KNEE SYSTEM
K110404
Corentec Co., Ltd.
Orthopedic · 367d
Cleared Feb 15, 2012
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K113378
Conformis, Inc.
Orthopedic · 91d
Cleared Feb 03, 2012
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
K120068
Conformis, Inc.
Orthopedic · 25d
Cleared Jan 27, 2012
GMK RESUFACING PATELLA SIZE 4
K113571
Medacta International
Orthopedic · 56d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
K112941
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 15, 2011
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K112780
Conformis, Inc.
Orthopedic · 80d
Cleared Dec 09, 2011
EVOLUTION MP ADAPTIVE CS INSERT
K113325
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Oct 13, 2011
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
K111492
Materialise NV
Orthopedic · 135d
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 Aug 02, 2011
UNITED U2 XPE TOTAL KNEE SYSTEM
K103733
United Orthopedic Corporation
Orthopedic · 223d
Cleared Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K111400
Exactech, Inc.
Orthopedic · 70d
Cleared May 27, 2011
GMK REVISION HYBRID LINERS
K111283
Medacta International
Orthopedic · 21d
Cleared May 05, 2011
HLS KNEETEC SYSTEM
K094013
Tornier
Orthopedic · 492d
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 Mar 03, 2011
VANGUARD REMOVABLE MOLDED POLY TIBIA
K102580
Biomet Manufacturing Corp
Orthopedic · 176d
Cleared Feb 28, 2011
VANGUARD ASYMMETRICAL PATELLAR COMPONENT
K110362
Biomet Manufacturing Corp
Orthopedic · 20d
Cleared Feb 23, 2011
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
K102125
Biomet, Inc.
Orthopedic · 209d
Cleared Feb 02, 2011
SIGNATURE PLANNER
K102795
Materialise NV
Orthopedic · 128d
Cleared Jan 07, 2011
EVOLUTION MP TOTAL KNEE SYSTEM
K102380
Wrightmedicaltechnologyinc
Orthopedic · 137d
Cleared Jan 07, 2011
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K103117
Conformis, Inc.
Orthopedic · 78d
Cleared Oct 22, 2010
VANGUARD 360 REVISION KNEE SYSTEM
K093293
Biomet, Inc.
Orthopedic · 366d