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
697–720 of 915
Cleared Jan 30, 1995
OSTEONICS(R) SERIES 7000 TOTAL KNEE
K940813
Osteonics Corp.
Orthopedic · 342d
Cleared Jan 27, 1995
APOLLO KNEE FEMORAL COMPONENT
K933229
Intermedics Orthopedics
Orthopedic · 574d
Cleared Jan 27, 1995
DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY
K943299
Depuy, Inc.
Orthopedic · 202d
Cleared Jan 18, 1995
KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K936274
Kirschner Medical Corp.
Orthopedic · 384d
Cleared Jan 17, 1995
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
K933610
Exactech, Inc.
Orthopedic · 539d
Cleared Jan 17, 1995
ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT
K941755
Wrightmedicaltechnologyinc
Orthopedic · 284d
Cleared Jan 09, 1995
RICHARDS TOTAL KNEE SYSTEM
K933958
Smith & Nephew Richards, Inc.
Orthopedic · 514d
Cleared Dec 21, 1994
DARWIN KNEE SYSTEM
K943462
Johnson & Johnson Professionals, Inc.
Orthopedic · 156d
Cleared Dec 19, 1994
OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS
K944285
Osteonics Corp.
Orthopedic · 108d
Cleared Dec 15, 1994
ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT
K944845
Wrightmedicaltechnologyinc
Orthopedic · 76d
Cleared Dec 09, 1994
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773
Exactech, Inc.
Orthopedic · 371d
Cleared Dec 08, 1994
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
K941128
Osteonics Corp.
Orthopedic · 274d
Cleared Dec 06, 1994
PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI
K931466
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 622d
Cleared Nov 10, 1994
PCA MODULAR PRIMARY/REVISION PATELLA
K940713
Howmedica Corp.
Orthopedic · 266d
Cleared Nov 08, 1994
FOUNDATION POSTERIOR STABILIZED KNEE
K933539
Encore Orthopedics, Inc.
Orthopedic · 475d
Cleared Oct 20, 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776
Exactech, Inc.
Orthopedic · 499d
Cleared Oct 20, 1994
EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
K935726
Exactech, Inc.
Orthopedic · 323d
Cleared Oct 18, 1994
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
K926334
Orthomet, Inc.
Orthopedic · 671d
Cleared Oct 14, 1994
AXIOM TOTAL KNEE SYSTEM
K932677
Orthomet, Inc.
Orthopedic · 499d
Cleared Oct 07, 1994
NUFFIELD TOTAL KNEE
K931960
Turnkey Intergration USA, Inc.
Orthopedic · 534d
Cleared Oct 05, 1994
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT
K940235
Wrightmedicaltechnologyinc
Orthopedic · 260d
Cleared Oct 03, 1994
S-ROM NOILES CRUCIATE RETAINING KNEE
K936037
Joint Medical Products Corp.
Orthopedic · 287d
Cleared Sep 27, 1994
CONSENSUS KNEE SYSTEM - PRIMARY KNEE
K932837
U.S. Medical Products, Inc.
Orthopedic · 473d
Cleared Sep 07, 1994
ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT
K932210
Dow Corning Wright
Orthopedic · 488d