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
433–456 of 914
Cleared Jul 22, 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313
Aesculap, Inc.
Orthopedic · 88d
Cleared Jul 17, 2002
HLS NOETOS SYSTEM
K013906
Tornier
Orthopedic · 233d
Cleared Jul 12, 2002
3D KNEE
K020114
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Jul 09, 2002
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
K021908
Stelkast Company
Orthopedic · 29d
Cleared Jun 06, 2002
SCORPIO INSET PATELLAR COMPONENT
K020830
Howmedica Osteonics Corp.
Orthopedic · 84d
Cleared Jun 05, 2002
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559
Biomet, Inc.
Orthopedic · 23d
Cleared May 06, 2002
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
K020383
Ortho Development Corp.
Orthopedic · 90d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS
K012778
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Feb 12, 2002
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA
K020295
Implex Corp.
Orthopedic · 15d
Cleared Dec 27, 2001
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K013991
Zimmer, Inc.
Orthopedic · 23d
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866
Implex Corp.
Orthopedic · 30d
Cleared Aug 15, 2001
MAXIM RPG PS FEMORAL COMPONENT
K012348
Biomet, Inc.
Orthopedic · 22d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251
Exactech, Inc.
Orthopedic · 13d
Cleared Jul 26, 2001
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)
K012095
Implex Corp.
Orthopedic · 21d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)
K011904
Implex Corp.
Orthopedic · 30d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976
Exactech, Inc.
Orthopedic · 21d
Cleared Jun 28, 2001
SCORPIO CR SUPERFLEX TIBIAL INSERT
K011643
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jun 27, 2001
ORTHOGENESIS LPS SYSTEM
K003182
Depuy, Inc.
Orthopedic · 259d
Cleared Jun 19, 2001
PFC SIGMA LUGGED TIBIAL TRAY
K003026
DePuy Orthopaedics, Inc.
Orthopedic · 264d
Cleared May 24, 2001
TC-PLUS POROUS FEMORAL COMPONENTS
K011258
Plus Orthopedics
Orthopedic · 30d
Cleared May 24, 2001
TC-PLUS POROUS TIBIAL COMPONENTS
K011288
Plus Orthopedics
Orthopedic · 27d
Cleared May 18, 2001
ASCENT KNEE SYSTEM
K011219
Biomet, Inc.
Orthopedic · 28d
Cleared May 17, 2001
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K010101
Kinamed, Inc.
Orthopedic · 126d