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
265–288 of 915
Cleared Jul 15, 2014
GMK SPHERE EXTENSION
K140826
Medacta International
Orthopedic · 105d
Cleared Jul 14, 2014
CONSENSUS VITALITE TIBIAL INSERT
K133919
Consensus Orthopedics, Inc.
Orthopedic · 203d
Cleared Jul 11, 2014
EXPRT REVISION KNEE
K140830
Encore Medical, L.P.
Orthopedic · 100d
Cleared Jul 03, 2014
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
K140902
Biomet, Inc.
Orthopedic · 85d
Cleared Jun 30, 2014
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K140833
Conformis, Inc.
Orthopedic · 89d
Cleared Jun 16, 2014
U2 FEMORAL COMPONENT, CR, CEMENTED
K140073
United Orthopedic Corp.
Orthopedic · 154d
Cleared May 29, 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared May 27, 2014
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K140423
Conformis, Inc.
Orthopedic · 98d
Cleared May 22, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
K140027
Materialise NV
Orthopedic · 136d
Cleared May 16, 2014
KLASSIC KNEE TIBIAL STEM EXTENSION
K140942
Total Joint Orthopedics, Inc.
Orthopedic · 32d
Cleared Mar 28, 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560
Conformis, Inc.
Orthopedic · 128d
Cleared Mar 25, 2014
VEGA KNEE SYSTEM
K140452
Aesculap Implant Systems
Orthopedic · 29d
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 21, 2014
FREEDOM PCK COMPONENTS
K131481
Maxx Orthopedics, Inc.
Orthopedic · 275d
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