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
313–336 of 914
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 Sep 16, 2010
ITOTAL CR KNEE REPLACEMENT SYSTEM
K094050
Conformis, Inc.
Orthopedic · 259d
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 Jun 18, 2010
MOTIVATION KNEE SYSTEM
K100900
Encore Medical, L.P.
Orthopedic · 79d
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
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 Nov 19, 2009
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)
K091263
Materialise NV
Orthopedic · 203d
Cleared Oct 09, 2009
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
K090705
Ortho Development Corp.
Orthopedic · 206d
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 24, 2008
VANGUARD CR STEM HOUSINGS
K082826
Biomet Manufacturing Corp
Orthopedic · 29d
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 Jun 17, 2008
E-POLY TIBIAL BEARINGS
K080528
Biomet Orthopedics, Inc.
Orthopedic · 112d
Cleared Jun 06, 2008
PROVEN STEM EXTENDER
K081458
Stelkast Company
Orthopedic · 14d
Cleared May 12, 2008
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
K080936
Conformis, Inc.
Orthopedic · 40d
Cleared Mar 20, 2008
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
K080204
Biomet, Inc.
Orthopedic · 52d