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
97–120 of 192
Cleared May 05, 2011
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C
K103835
Howmedica Osteonics Corp.
Orthopedic · 126d
Cleared Apr 27, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K110865
Tornier, Inc.
Orthopedic · 29d
Cleared Jan 31, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K102924
Tornier, Inc.
Orthopedic · 123d
Cleared Jan 24, 2011
TOTAL SHOULDER SYSTEM
K102670
Shoulder Innovations, LLC
Orthopedic · 130d
Cleared Dec 22, 2010
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K103466
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 13, 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
K103419
Exactech, Inc.
Orthopedic · 21d
Cleared Nov 24, 2010
ARROW ANATOMICAL SHOULDER SYSTEM
K093599
Fournitures Hospitalieres Industrie
Orthopedic · 369d
Cleared Nov 22, 2010
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
K103104
Howmedica Osteonics Corp.
Orthopedic · 33d
Cleared Nov 09, 2010
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
K103007
Tornier, Inc.
Orthopedic · 28d
Cleared Sep 02, 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
K093430
Exactech, Inc.
Orthopedic · 303d
Cleared Aug 30, 2010
ASCENSION MODULAR TOTAL SHOULDER SYSTEM
K100448
Ascension Orthopedics, Inc.
Orthopedic · 194d
Cleared Oct 27, 2009
GRS GLENOID RESURFACING SYSTEM
K091196
Arthrosurface, Inc.
Orthopedic · 187d
Cleared Jul 27, 2009
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
K092122
DePuy Orthopaedics, Inc.
Orthopedic · 13d
Cleared Jul 14, 2009
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
K091751
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Jun 26, 2009
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
K083435
Arthrex, Inc.
Orthopedic · 218d
Cleared Oct 24, 2008
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
K082120
Tornier
Orthopedic · 88d
Cleared Jul 17, 2008
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
K081707
Tornier, Inc.
Orthopedic · 30d
Cleared Jun 30, 2008
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
K081620
DePuy Orthopaedics, Inc.
Orthopedic · 21d
Cleared Mar 28, 2008
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
K080402
Encore Medical, L.P.
Orthopedic · 43d
Cleared Aug 20, 2007
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K071032
Arthrex, Inc.
Orthopedic · 131d
Cleared Jun 29, 2007
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
K071090
Zimmer Trabecular Metal Technology
Orthopedic · 72d
Cleared Dec 11, 2006
MODULAR HYBRID GLENOID
K060694
Biomet Manufacturing Corp
Orthopedic · 271d
Cleared Dec 06, 2006
TOTAL AND HEMI SHOULDER SYSTEM
K060988
Dvo Extremity Solutions, LLC
Orthopedic · 240d
Cleared Oct 31, 2006
ANATOMICAL SHOULDER FRACTURE SYSTEM
K062029
Zimmer GmbH
Orthopedic · 105d