ClearanceBrief
Panels › Orthopedic › Product code KWS · Class 2

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Regulation 888.3660

3510(k)s in 12 months (191 all time)
4recalls in 12 months (153 all time)
131recalls that name a 510(k)
Get daily alerts for KWSSample briefCSV

Top companies in KWS

Company510(k)sRecalls
Encore Medical L.P.935
Exactech, Inc.823
Tornier246
Zimmer GmbH720
Biomet, Inc.421
DePuy Orthopaedics, Inc.911
Tournier, Inc.018
Smith & Nephew, Inc.116
Arthrex, Inc.150
Lima Corporate S.P.A.80
Decided510(k)Device and applicantCode
Dec 13, 2010K103419EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
Exactech, Inc.
KWS
Nov 24, 2010K093599ARROW ANATOMICAL SHOULDER SYSTEM
Fournitures Hospitalieres Industrie, FR
KWS
Nov 22, 2010K103104SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
Howmedica Osteonics Corp.
KWS
Nov 9, 2010K103007AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
Tornier, Inc.
KWS
Sep 2, 2010K093430EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
Exactech, Inc.
KWS
Aug 30, 2010K100448ASCENSION MODULAR TOTAL SHOULDER SYSTEM
Ascension Orthopedics, Inc.
KWS
Oct 27, 2009K091196GRS GLENOID RESURFACING SYSTEM
Arthrosurface, Inc.
KWS
Jul 27, 2009K092122GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
DePuy Orthopaedics, Inc.
KWS
Jul 14, 2009K091751DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
DePuy Orthopaedics, Inc.
KWS
Jun 26, 2009K083435ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
Arthrex, Inc.
KWS
Oct 24, 2008K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
Tornier, FR
KWS
Jul 17, 2008K081707AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
Tornier, Inc.
KWS
Jun 30, 2008K081620MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
DePuy Orthopaedics, Inc.
KWS
Mar 28, 2008K080402ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
Encore Medical L.P.
KWS
Aug 20, 2007K071032ARTHREX UNIVERS II SHOULDER PROSTHESIS
Arthrex, Inc.
KWS
Jun 29, 2007K071090TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
Zimmer Trabecular Metal Technology
KWS
Dec 11, 2006K060694MODULAR HYBRID GLENOID
Biomet Manufacturing Corp
KWS
Dec 6, 2006K060988TOTAL AND HEMI SHOULDER SYSTEM
Dvo Extremity Solutions, LLC
KWS
Oct 31, 2006K062029ANATOMICAL SHOULDER FRACTURE SYSTEM
Zimmer GmbH
KWS
Oct 3, 2006K062113SOLAR REUNION FRACTURE STEM
Howmedica Osteonics Corp.
KWS
Jun 28, 2006K060874DEPUY GLOBAL AP SHOULDER SYSTEM
DePuy Orthopaedics, Inc.
KWS
Mar 2, 2006K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
Tornier, FR
KWS
Oct 6, 2005K052472DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
DePuy Orthopaedics, Inc.
KWS
Jul 19, 2005K051623ANATOMICAL SHOULDER KEELED GLENOID
Zimmer GmbH
KWS
Jan 31, 2005K043346GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
Genesis Medical LLC
KWS
Dec 17, 2004K043077MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
Tornier, FR
KWS
Nov 23, 2004K043061THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
Zimmer Trabecular
KWS
Oct 26, 2004K042021EXACTECH EQUINOXE SHOULDER SYSTEM
Exactech, Inc.
KWS
Jun 17, 2004K041339AEQUALIS SHOULDER SYSTEM
Tornier, FR
KWS
Jun 4, 2004K040610VERSA-DIAL HUMERAL HEAD
Biomet Manufacturing, Inc.
KWS
Feb 2, 2004K033506COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
Biomet, Inc.
KWS
Dec 15, 2003K032679AEQUALIS SHOULDER FRACTURE SYSTEM
Tornier, FR
KWS
Sep 23, 2003K031449MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
Implex Corp.
KWS
Apr 24, 2003K030259AMATOMICAL SHOULDER WITH REMOVABLE HEAD
Centerplus Orthopedics, Inc.
KWS
Mar 4, 2003K030344MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
Smith & Nephew, Inc.
KWS
Sep 6, 2002K020345ARTHREX UNIVERS FRACTURE PROSTHESIS
Arthrex, Inc.
KWS
Mar 15, 2002K012788VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
Smith & Nephew, Inc.
KWS
Dec 13, 2001K0123783D HUMERAL HEADS
Smith & Nephew, Inc.
KWS
Dec 6, 2001K003324PLASMA SPRAYED SHOULDER
Encore Orthopedics, Inc.
KWS
Aug 15, 2001K012212MODIFICATION TO AEQUALIS SHOULDER SYSTEM
Tornier, FR
KWS
Apr 6, 2001K010124ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
Arthrex, Inc.
KWS
Feb 28, 2001K003801ANATOMICAL PRESS-FIT HUMERAL STEM
Sulzer Orthopedics, Inc.
KWS
Feb 14, 2001K003566COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
Smith & Nephew, Inc.
KWS
Jan 4, 2001K003832SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
Sulzer Orthopedics, Inc.
KWS
Dec 20, 2000K003728MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
Tornier
KWS
Nov 22, 2000K002683WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
Wrightmedicaltechnologyinc
KWS
Aug 16, 2000K001706WMT MODULAR SHOULDER SYSTEM
Wrightmedicaltechnologyinc
KWS
Jun 22, 2000K994393AEQUALIS UNIVERSAL SHOULDER GLENOID
Tornier
KWS
Jun 8, 2000K001046BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
Biopro, Inc.
KWS
May 23, 2000K994350NEER III TOTAL SHOULDER SYSTEM
Smith & Nephew, Inc.
KWS

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.