KWS · Class II · 21 CFR 888.3660

FDA Product Code KWS: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Under FDA product code KWS, semi-constrained shoulder prostheses with metal and polymer bearing surfaces are cleared for total shoulder arthroplasty.

These anatomical shoulder replacement systems reproduce the natural ball-and-socket geometry of the glenohumeral joint, with a metal humeral head articulating against a polymer glenoid component. They are indicated for patients with intact or repairable rotator cuff function.

KWS devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Tornier, Inc. and Tornier.

192
Total
192
Cleared
117d
Avg days
1980
Since
192 devices
121–144 of 192
Cleared Oct 03, 2006
SOLAR REUNION FRACTURE STEM
K062113
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Jun 28, 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
K060874
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Mar 02, 2006
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
K060209
Tornier
Orthopedic · 34d
Cleared Oct 06, 2005
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Jul 19, 2005
ANATOMICAL SHOULDER KEELED GLENOID
K051623
Zimmer GmbH
Orthopedic · 29d
Cleared Jan 31, 2005
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
K043346
Genesis Medical LLC
Orthopedic · 56d
Cleared Dec 17, 2004
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077
Tornier
Orthopedic · 39d
Cleared Nov 23, 2004
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
K043061
Zimmer Trabecular
Orthopedic · 18d
Cleared Oct 26, 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021
Exactech, Inc.
Orthopedic · 90d
Cleared Jun 17, 2004
AEQUALIS SHOULDER SYSTEM
K041339
Tornier
Orthopedic · 28d
Cleared Jun 04, 2004
VERSA-DIAL HUMERAL HEAD
K040610
Biomet Manufacturing, Inc.
Orthopedic · 88d
Cleared Feb 02, 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506
Biomet, Inc.
Orthopedic · 89d
Cleared Dec 15, 2003
AEQUALIS SHOULDER FRACTURE SYSTEM
K032679
Tornier
Orthopedic · 108d
Cleared Sep 23, 2003
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
K031449
Implex Corp.
Orthopedic · 139d
Cleared Apr 24, 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259
Centerplus Orthopedics, Inc.
Orthopedic · 90d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 06, 2002
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345
Arthrex, Inc.
Orthopedic · 217d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
K012788
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 06, 2001
PLASMA SPRAYED SHOULDER
K003324
Encore Orthopedics, Inc.
Orthopedic · 408d
Cleared Aug 15, 2001
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
K012212
Tornier
Orthopedic · 30d
Cleared Apr 06, 2001
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
K010124
Arthrex, Inc.
Orthopedic · 80d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801
Sulzer Orthopedics, Inc.
Orthopedic · 82d
Cleared Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566
Smith & Nephew, Inc.
Orthopedic · 86d