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
457–480 of 914
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
Cleared Jan 25, 2001
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
K004013
Implex Corp.
Orthopedic · 29d
Cleared Jan 12, 2001
MAXIM KNEE SYSTEM
K010027
Biomet, Inc.
Orthopedic · 9d
Cleared Nov 30, 2000
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
K002740
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 06, 2000
BIOMET SCK KNEE SYSTEM
K003296
Biomet, Inc.
Orthopedic · 17d
Cleared Oct 25, 2000
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
K002335
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Oct 13, 2000
TC-PLUS SOLUTION KNEE
K000666
Plus Orthopedics
Orthopedic · 228d
Cleared Oct 04, 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772
Biomet, Inc.
Orthopedic · 28d
Cleared Sep 19, 2000
ASCENT KNEE SYSTEM
K002678
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 19, 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735
Biomet, Inc.
Orthopedic · 18d
Cleared Aug 17, 2000
STELKAST PROVEN KNEE SYSTEM
K002281
Stelkast Company
Orthopedic · 24d
Cleared Jul 19, 2000
GEM KNEE SYSTEM
K994214
Kinamed, Inc.
Orthopedic · 218d
Cleared Jun 22, 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978
Biomet, Inc.
Orthopedic · 87d
Cleared May 23, 2000
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
K001307
Implex Corp.
Orthopedic · 29d
Cleared May 11, 2000
LATERAL PIVOT INSERT
K000590
Encore Orthopedics, Inc.
Orthopedic · 80d
Cleared Apr 27, 2000
ASCENT KNEE REVISION FEMORAL STEM
K001010
Biomet, Inc.
Orthopedic · 29d
Cleared Apr 04, 2000
PROVEN KNEE SYSTEM
K000113
Stelkast Company
Orthopedic · 81d
Cleared Mar 24, 2000
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
K994370
Ortho Development Corp.
Orthopedic · 88d
Cleared Mar 10, 2000
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
K000091
Howmedica Osteonics Corp.
Orthopedic · 57d
Cleared Mar 06, 2000
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
K994128
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Feb 25, 2000
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
K000232
Corin USA
Orthopedic · 29d
Cleared Feb 18, 2000
IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY
K994076
Implex Corp.
Orthopedic · 78d