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
241–264 of 911
Cleared Jan 11, 2010
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
K093360
Exactech, Inc.
Orthopedic · 75d
Cleared Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
K091014
Smith & Nephew, Inc.
Orthopedic · 173d
Cleared Aug 20, 2009
ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE
K092201
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Jul 10, 2009
GMK TOTAL KNEE SYSTEM
K090988
Medacta International S.A.
Orthopedic · 94d
Cleared Nov 25, 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
K082358
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Nov 18, 2008
DEPUY SIGMA CR-F FEMORAL COMPONENT
K082500
DePuy Orthopaedics, Inc.
Orthopedic · 81d
Cleared Oct 22, 2008
EVOLIS TOTAL KNEE SYSTEM
K081023
Medacta International S.A.
Orthopedic · 195d
Cleared Sep 02, 2008
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
K082022
Exactech, Inc.
Orthopedic · 48d
Cleared Mar 20, 2008
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
K080204
Biomet, Inc.
Orthopedic · 52d
Cleared Mar 07, 2008
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K073286
Zimmer, Inc.
Orthopedic · 107d
Cleared Jan 24, 2008
DEPUY SIGMA PS FEMORAL COMPONENTS
K073529
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Dec 20, 2007
DEPUY LPS DISTAL FEMORAL COMPONENT
K063686
DePuy Orthopaedics, Inc.
Orthopedic · 373d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 20, 2007
TC-PLUS PRIMARY KNEE SYSTEM
K072858
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Oct 15, 2007
MODIFICATION TO TRIATHLON TS KNEE SYSTEM
K072221
Howmedica Osteonics Corp.
Orthopedic · 66d
Cleared Sep 19, 2007
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071
Smith & Nephew, Inc.
Orthopedic · 156d
Cleared Sep 06, 2007
NEXGEN PROLONG ALL-POLY PATELLA
K072281
Zimmer, Inc.
Orthopedic · 21d
Cleared Aug 15, 2007
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
K071738
Exactech, Inc.
Orthopedic · 50d
Cleared Aug 15, 2007
MODIFICATION TO SCORPIO NRG KNEE SYSTEM
K071991
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Jun 01, 2007
TRIATHLON TS KNEE SYSTEM
K070095
Howmedica Osteonics Corp.
Orthopedic · 142d
Cleared Mar 02, 2007
DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
K063633
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Oct 13, 2006
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL
K062768
Zimmer, Inc.
Orthopedic · 28d
Cleared Aug 03, 2006
TRIATHLON LOW PROFILE TIBIAL TRAY
K062037
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Aug 01, 2006
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES
K061882
Zimmer, Inc.
Orthopedic · 29d