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
313–336 of 911
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 Oct 18, 2002
DURACON CS TIBIAL INSERT
K021451
Howmedica Osteonics Corp.
Orthopedic · 165d
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 Jul 22, 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313
Aesculap, Inc.
Orthopedic · 88d
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 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 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 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 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 18, 2001
ASCENT KNEE SYSTEM
K011219
Biomet, Inc.
Orthopedic · 28d
Cleared Mar 19, 2001
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K003910
Zimmer, Inc.
Orthopedic · 90d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 15, 2001
ENHANCED POLYETHYLENE KNEE PROSTHESES
K001147
Howmedica Osteonics Corp.
Orthopedic · 311d