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
625–648 of 915
Cleared Oct 21, 1997
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT
K972770
Wrightmedicaltechnologyinc
Orthopedic · 89d
Cleared Oct 01, 1997
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
K972501
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Sep 29, 1997
ADVANCE KNEE SYSTEM
K972626
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Jul 31, 1997
APOLLO KNEE FEMORAL SPACERS
K971770
Sulzer Orthopedics, Inc.
Orthopedic · 79d
Cleared Jul 24, 1997
IMPLEX CONTINUUM POROUS PATELLAR
K971789
Implex Corp.
Orthopedic · 71d
Cleared Jul 17, 1997
P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)
K971189
Johnson & Johnson Professionals, Inc.
Orthopedic · 107d
Cleared Jul 16, 1997
P.F.C. SIGMA INSET PATELLA
K971652
Johnson & Johnson Professionals, Inc.
Orthopedic · 71d
Cleared Jul 08, 1997
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
K971550
Howmedica Corp.
Orthopedic · 71d
Cleared Jun 11, 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K965173
Howmedica Corp.
Orthopedic · 169d
Cleared May 22, 1997
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE
K970758
Howmedica Corp.
Orthopedic · 80d
Cleared Apr 30, 1997
NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
K970498
Intermedics Orthopedics
Orthopedic · 79d
Cleared Apr 02, 1997
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
K970031
Encore Orthopedics, Inc.
Orthopedic · 89d
Cleared Mar 17, 1997
KIRSCHNER KNEE MODIFIED
K961021
Biomet, Inc.
Orthopedic · 368d
Cleared Feb 24, 1997
KINEMAX PLUS TIBIAL SPACERS
K964951
Howmedica Corp.
Orthopedic · 76d
Cleared Feb 13, 1997
NEXGEN COMPLETE KNEE SOLUTION
K963148
Zimmer, Inc.
Orthopedic · 184d
Cleared Jan 02, 1997
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
K963255
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 136d
Cleared Dec 27, 1996
FOUNDATION KNEE SYSTEM
K964008
Encore Orthopedics, Inc.
Orthopedic · 81d
Cleared Dec 09, 1996
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
K963796
Howmedica Corp.
Orthopedic · 77d
Cleared Dec 05, 1996
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
K962557
Smith & Nephew Richards, Inc.
Orthopedic · 157d
Cleared Dec 04, 1996
CEMENT-ON FEMORAL STEM
K963709
Biomet, Inc.
Orthopedic · 79d
Cleared Nov 27, 1996
KONSTRUCT PATELLAR COMPONENT
K960856
Biomet, Inc.
Orthopedic · 271d
Cleared Nov 14, 1996
DURACON POSTERIOR FEMORAL SPACER
K963242
Howmedica Corp.
Orthopedic · 87d
Cleared Nov 06, 1996
P.F.C. CRUCIATE RETAING KNEE SYSTEM
K963117
Johnson & Johnson Professionals, Inc.
Orthopedic · 86d
Cleared Oct 01, 1996
TIBIAL INSERT
K963028
Encore Orthopedics, Inc.
Orthopedic · 57d