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
241–264 of 914
Cleared Mar 28, 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560
Conformis, Inc.
Orthopedic · 128d
Cleared Mar 13, 2014
ULTRACONGRUENT INSERT
K132752
United Orthopedic Corporation
Orthopedic · 191d
Cleared Feb 27, 2014
ARTHREX IBALANCE TKA SYSTEM
K133854
Arthrex, Inc.
Orthopedic · 70d
Cleared Feb 25, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
K133162
Materialise NV
Orthopedic · 131d
Cleared Feb 18, 2014
KASM KNEE ARTICULATING SPACER MOLDS
K133449
Ortho Development Corp.
Orthopedic · 98d
Cleared Feb 04, 2014
ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
K133737
Zimmer, Inc.
Orthopedic · 57d
Cleared Jan 15, 2014
U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
K131864
United Orthopedic Corporation
Orthopedic · 205d
Cleared Jan 09, 2014
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
K133256
Conformis, Inc.
Orthopedic · 78d
Cleared Dec 20, 2013
GMK SHORT STEM
K133630
Medacta International
Orthopedic · 24d
Cleared Dec 17, 2013
ARTHREX IBALANCE TKA SYSTEM
K133342
Arthrex, Inc.
Orthopedic · 48d
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708
Smith & Nephew, Inc.
Orthopedic · 271d
Cleared Oct 30, 2013
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
K131116
United Orthopedic Corporation
Orthopedic · 191d
Cleared Oct 23, 2013
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
K131679
Wrightmedicaltechnologyinc
Orthopedic · 135d
Cleared Oct 11, 2013
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
K131337
Ortho Development Corp.
Orthopedic · 155d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
K132161
Exactech, Inc.
Orthopedic · 91d
Cleared Aug 22, 2013
GMK FULL PE TIBIAL COMPONENTS
K131310
Medacta International
Orthopedic · 107d
Cleared Aug 05, 2013
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
K122883
Stelkast Company
Orthopedic · 319d
Cleared Jul 26, 2013
GMK REVISION EXTENSION
K123721
Medacta International
Orthopedic · 234d
Cleared Jul 18, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K131467
Conformis, Inc.
Orthopedic · 58d
Cleared May 24, 2013
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
K131019
Conformis, Inc.
Orthopedic · 42d
Cleared May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Apr 15, 2013
LOSPA TOTAL KNEE REPLACEMENT SYSTEM
K130673
Corentec Co., Ltd.
Orthopedic · 34d
Cleared Apr 11, 2013
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING
K122239
Encore Medical, L.P.
Orthopedic · 258d
Cleared Mar 22, 2013
BALANCED KNEE SYSTEM HIGH FLEX PS
K123457
Ortho Development Corp.
Orthopedic · 134d