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
265–288 of 911
Cleared May 26, 2006
NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT
K060722
Zimmer, Inc.
Orthopedic · 70d
Cleared May 17, 2006
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
K053579
Aesculap, Inc.
Orthopedic · 146d
Cleared May 03, 2006
LEGION COBALT CHROME REVISION KNEE SYSTEM
K060742
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared Apr 28, 2006
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
K060370
Zimmer, Inc.
Orthopedic · 74d
Cleared Mar 23, 2006
DEPUY PFC SIGMA KNEE PROSTHESIS
K060515
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Feb 06, 2006
COLUMBUS (CR) TOTAL KNEE SYSTEM
K053390
Aesculap, Inc.
Orthopedic · 63d
Cleared Nov 22, 2005
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
K052879
Zimmer, Inc.
Orthopedic · 41d
Cleared Oct 12, 2005
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
K051977
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Jul 20, 2005
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
K051229
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 19, 2005
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
K050210
Biomet, Inc.
Orthopedic · 172d
Cleared Jul 13, 2005
TRIATHLON KNEE SYSTEM
K051146
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Apr 20, 2005
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
K050723
Zimmer, Inc.
Orthopedic · 30d
Cleared Mar 29, 2005
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
K050539
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Mar 14, 2005
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
K042515
Smith & Nephew, Inc.
Orthopedic · 179d
Cleared Mar 11, 2005
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
K041825
Smith & Nephew, Inc.
Orthopedic · 247d
Cleared Mar 07, 2005
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
K043101
Zimmer, Inc.
Orthopedic · 118d
Cleared Feb 18, 2005
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
K043440
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Feb 11, 2005
VANGUARD SSK KNEE SYSTEM
K042757
Biomet, Inc.
Orthopedic · 130d
Cleared Feb 09, 2005
SCORPIO NRG KNEE SYSTEM
K042343
Howmedica Osteonics Corp.
Orthopedic · 163d
Cleared Jan 12, 2005
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
K042993
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Nov 23, 2004
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
K042883
Howmedica Osteonics Corp.
Orthopedic · 35d
Cleared Oct 13, 2004
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
K042271
Zimmer, Inc.
Orthopedic · 51d
Cleared Sep 23, 2004
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
K041591
Howmedica Osteonics Corp.
Orthopedic · 101d
Cleared Jul 22, 2004
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
K041085
Depuy, Inc.
Orthopedic · 87d