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
457–480 of 915
Cleared Oct 12, 2005
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
K051977
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Jul 27, 2005
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
K051756
Zimmer Trabecular
Orthopedic · 28d
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 Dec 07, 2004
AEQUOS
K033260
Aap Implantate AG
Orthopedic · 425d
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 30, 2004
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K040630
Implex Corp.
Orthopedic · 204d
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
Cleared Jul 09, 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281
DePuy Orthopaedics, Inc.
Orthopedic · 154d
Cleared Jul 01, 2004
LPS
K033959
Depuy, Inc.
Orthopedic · 192d
Cleared Jul 01, 2004
REVISION KNEE SYSTEM
K041106
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Jul 01, 2004
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
K041466
Biomet Manufacturing Corp
Orthopedic · 29d