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)
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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
Mar 10, 2000K994392AEQUALIS SHOULDER FRACTURE SYSTEM
Tornier
KWS
Mar 10, 2000K000575GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
DePuy Orthopaedics, Inc.
KWS
Oct 21, 1999K992899BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
Biomet, Inc.
KWS
Sep 13, 1999K992119BIO-MODULAR SHOULDER SYSTEM
Biomet, Inc.
KWS
Aug 23, 1999K980244AEQUALIS SHOULDER PROSTHESIS
Tornier
KWS
Jul 12, 1999K992065GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
DePuy Orthopaedics, Inc.
KWS
Mar 15, 1999K990598OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
Howmedica Osteonics Corp.
KWS
Mar 1, 1999K990136ANATOMICA GLENOID COMPONENT
Sulzer Orthopedics, Inc.
KWS
Feb 18, 1999K990137ANATOMICA HUMERAL STEM/HEAD COMPONENTS
Sulzer Orthopedics, Inc.
KWS
Jul 13, 1998K981487DEPUY GLOBAL SHOULDER GLENOID
DePuy Orthopaedics, Inc.
KWS
Jan 22, 1998K974044GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
DePuy Orthopaedics, Inc.
KWS
Aug 7, 1997K971715SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
Sulzer Orthopedics, Inc.
KWS
Aug 28, 1996K962224SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
Intermedics Orthopedics
KWS
Aug 13, 1996K962082OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
Osteonics Corp.
KWS
Apr 15, 1996K960906FOUNDATION GLENOID COMPONENT
Encore Orthopedics, Inc.
KWS
Apr 9, 1996K955944OSTEONICS N2/VAC PACKAGING PROCESS
Osteonics Corp.
KWS
Apr 8, 1996K955767COFIED MODULAR SHOULDER SYSTEM
Smith & Nephew Richards, Inc.
KWS
Mar 5, 1996K955731OSTEONICS SHOULDER HUMERAL COMPONENTS
Osteonics Corp.
KWS
Sep 27, 1995K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
Tornier
KWS
Jun 16, 1995K950521OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
Osteonics Corp.
KWS
May 30, 1995K950651TOTAL SHOULDER PROSTHESIS
Encore Orthopedics, Inc.
KWS
May 22, 1995K935802SELECT(R) SHOULDER ALL POLY GLENOID
Intermedics Orthopedics
KWS
Oct 31, 1994K943300DEPUY POROUS COATED GLOBAL SHOULDER
Depuy, Inc.
KWS
Jul 22, 1993K9203623M MODULAR SHOULDER SYSTEM
3M Health Care, Ltd.
KWS
Jan 28, 1991K904880BUECHEL-PAPPAS HUMERAL STEM COMPONENT
Endotec, Inc.
KWS
Jan 28, 1991K904879BEUCHEL-PAPPAS GLENOID COMPONENT
Endotec, Inc.
KWS
Nov 20, 1990K903886OSTEONICS SR GLENOID COMPONENTS
Osteonics Reconstructive Products Div.
KWS
Sep 20, 1990K902855NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
Depuy, Inc.
KWS
Jun 8, 1990K901434PAPILLOTOME
Telemed Systems, Inc.
KWS
Nov 3, 1989K895226NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
3M Company
KWS
Apr 27, 1989K884943INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
Intermedics Orthopedics
KWS
Nov 10, 1988K883816SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
Osteonics Corp.
KWS
Aug 30, 1988K881750NORMAL HUMERAL PROSTHESIS
Osteonics Corp.
KWS
Aug 29, 1988K881836INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP
Intermedics Orthopedics
KWS
Apr 3, 1987K870262FENLIN II SHOULDER PROSTHESIS
Zimmer, Inc.
KWS
Sep 2, 1986K862535OSTEONICS SHOULDER PROSTHESIS
Osteonics Corp.
KWS
Mar 26, 1986K855183COFIELD SHOULDER SYSTEM
Richards Medical Co., Inc.
KWS
Dec 16, 1985K852365LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM
Link America, Inc.
KWS
Jan 10, 1985K843624COFIELD SHOULDER SYSTEM
Richards Medical Co., Inc.
KWS
Nov 7, 1983K833410MONOSPHERICAL GLENOID PROSTH. KEEL
Howmedica Corp.
KWS
Dec 31, 1980K801970UCLA SHOULDER
Howmedica Corp.
KWS

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