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
337–360 of 915
Cleared Apr 19, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K120316
Conformis, Inc.
Orthopedic · 78d
Cleared Apr 02, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE
K113829
Materialise NV
Orthopedic · 97d
Cleared Mar 27, 2012
ZIMMER PERSONA KNEE SYSTEM
K113369
Zimmer, Inc.
Orthopedic · 133d
Cleared Mar 20, 2012
PIPELINE CR PRIMARY KNEE SYSTEM
K113122
Pipeline Orthopedics
Orthopedic · 151d
Cleared Feb 29, 2012
APEX REVISION KNEE SYSTEMS
K112891
Omni Life Science, Inc.
Orthopedic · 152d
Cleared Feb 29, 2012
VANGUARD COMPLETE KNEE SYSTEM
K113550
Biomet Manufacturing Corp
Orthopedic · 90d
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 Feb 01, 2012
KLASSIC KNEE SYSTEM
K112906
Total Joint Orthopedics, Inc.
Orthopedic · 121d
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 Nov 04, 2011
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED
K112285
Tgm Medical, Inc.
Orthopedic · 87d
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 Jul 13, 2011
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
K111062
Omni Life Science, Inc.
Orthopedic · 86d
Cleared Jun 22, 2011
APEX PS KNEE SYSTEM - PS-C INSERT
K111184
Omni Life Science, Inc.
Orthopedic · 56d
Cleared May 27, 2011
GMK REVISION HYBRID LINERS
K111283
Medacta International
Orthopedic · 21d