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
289–312 of 911
Cleared Jul 09, 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281
DePuy Orthopaedics, Inc.
Orthopedic · 154d
Cleared Jul 01, 2004
LPS
K033959
Depuy, Inc.
Orthopedic · 192d
Cleared Jul 01, 2004
REVISION KNEE SYSTEM
K041106
Smith & Nephew, Inc.
Orthopedic · 64d
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 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 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 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 Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 03, 2003
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
K023724
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jan 17, 2003
MAXIM ACCEL KNEE SYSTEM
K023546
Biomet, Inc.
Orthopedic · 87d