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
481–504 of 915
Cleared May 28, 2004
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
K032522
Exactech, Inc.
Orthopedic · 287d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
K040964
Howmedica Osteonics Corp.
Orthopedic · 44d
Cleared May 21, 2004
MAXIM ACCEL (VANGUARD) PS+ BEARINGS
K041046
Biomet, Inc.
Orthopedic · 29d
Cleared May 05, 2004
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
K040267
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Apr 22, 2004
VANGUARD PATELLA COMPONENTS
K040770
Biomet Manufacturing, Inc.
Orthopedic · 28d
Cleared Feb 23, 2004
DEPUY SIGMA XLK TIBIAL INSERTS
K040166
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Feb 13, 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI
K033883
Exactech, Inc.
Orthopedic · 60d
Cleared Feb 05, 2004
DEPUY SIGMA TIBIAL INSERTS
K033272
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared Jan 15, 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jan 15, 2004
ADVANCE DOUBLE HIGH INSERT
K033890
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jan 08, 2004
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
K031962
Implex Corp.
Orthopedic · 197d
Cleared Dec 19, 2003
GEM INSET PATELLAR COMPONENT
K032950
Kinamed, Inc.
Orthopedic · 88d
Cleared Dec 10, 2003
SCORPIO LOW PROFILE TIBIAL TRAY
K032829
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Nov 20, 2003
SCORPIO NRG KNEE SYSTEM
K030978
Howmedica Osteonics Corp.
Orthopedic · 237d
Cleared Oct 10, 2003
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
K031901
Stelkast Company
Orthopedic · 112d
Cleared Oct 02, 2003
HLS NOETOS SYSTEM
K032079
Tornier
Orthopedic · 87d
Cleared Sep 26, 2003
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
K032151
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 23, 2003
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS
K032606
Exactech, Inc.
Orthopedic · 29d
Cleared Sep 04, 2003
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K032479
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 02, 2003
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
K031729
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Aug 21, 2003
COLUMBUS (PS)
K030367
Aesculap, Inc.
Orthopedic · 198d
Cleared Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 08, 2003
VKS/TC-PLUS REVISION KNEE
K032215
Plus Orthopedics
Orthopedic · 18d
Cleared Jul 15, 2003
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
K031201
Ortho Development Corp.
Orthopedic · 90d