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
409–432 of 914
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
Cleared Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686
Exactech, Inc.
Orthopedic · 28d
Cleared Mar 25, 2003
PROVEN MODULAR TIBIAL TRAY
K030577
Stelkast Company
Orthopedic · 29d
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
Cleared Jan 15, 2003
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
K024161
Implex Corp.
Orthopedic · 29d
Cleared Dec 30, 2002
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
K024037
Biomet, Inc.
Orthopedic · 24d
Cleared Dec 13, 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788
Aesculap, Inc.
Orthopedic · 30d
Cleared Nov 13, 2002
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
K020703
Howmedica Osteonics Corp.
Orthopedic · 254d
Cleared Nov 08, 2002
COLUMBUS TOTAL KNEE SYSTEM (CR)
K022672
Aesculap, Inc.
Orthopedic · 88d
Cleared Nov 08, 2002
MODIFICATION TO VKS KNEE SYSTEM
K023416
Plus Orthopedics
Orthopedic · 28d
Cleared Oct 18, 2002
DURACON CS TIBIAL INSERT
K021451
Howmedica Osteonics Corp.
Orthopedic · 165d
Cleared Oct 18, 2002
VKS KNEE SYSTEM
K022204
Plus Orthopedics
Orthopedic · 105d
Cleared Oct 17, 2002
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
K023186
Exactech, Inc.
Orthopedic · 23d
Cleared Oct 17, 2002
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211
Zimmer, Inc.
Orthopedic · 21d
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Aug 15, 2002
ANTERIOR STABILIZED TIBIAL BEARINGS
K022586
Biomet Orthopedics, Inc.
Orthopedic · 10d
Cleared Aug 09, 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578
Sulzer Orthopedics, Inc.
Orthopedic · 87d