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
385–408 of 915
Cleared Jun 18, 2010
MOTIVATION KNEE SYSTEM
K100900
Encore Medical, L.P.
Orthopedic · 79d
Cleared Jun 14, 2010
UNITED STEM, PSA TYPE
K100981
United Orthopedic Corp.
Orthopedic · 66d
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 05, 2010
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
K094017
Omni Life Science, Inc.
Orthopedic · 66d
Cleared Mar 04, 2010
EVOLUTION MP TOTAL KNEE SYSTEM
K093552
Wrightmedicaltechnologyinc
Orthopedic · 107d
Cleared Feb 05, 2010
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
K093567
Anova Implant Solutions, LLC
Orthopedic · 79d
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 Dec 23, 2009
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
K092803
Cardo Medical Corp.
Orthopedic · 103d
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 Sep 25, 2009
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
K091280
Maxx Orthopedics, Inc.
Orthopedic · 147d
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 Jun 04, 2009
COLUMBUS REVISION KNEE SYSTEM
K083772
Aesculap Implant System, Inc.
Orthopedic · 168d
Cleared Apr 07, 2009
FREEDOM METAL BACKED TIBIAL COMPONENT
K090411
Maxx Orthopedics, Inc.
Orthopedic · 48d
Cleared Feb 20, 2009
FANNING-PAPPAS MODULAR KNEE BEARING
K081400
Endotec, Inc.
Orthopedic · 277d
Cleared Feb 06, 2009
FREEDOM TOTAL KNEE SYSTEM
K082019
Maxx Orthopedics, Inc.
Orthopedic · 205d
Cleared Dec 16, 2008
UNITED U2 TOTAL KNEE SYSTEM
K082424
United Orthopedic Corp.
Orthopedic · 116d
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