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
Apr 26, 2016K153602Materialise Glenoid Positioning System
Materialise NV, BE
KWS
Apr 6, 2016K153722SMR 3-Pegs Glenoids
Lima Corporate S.P.A., IT
KWS
Mar 8, 2016K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
Zimmer GmbH, CH
KWS
Feb 19, 2016K153215SmartBase for Arthrex Glenoid IRIS
Custom Orthopaedic Solutions, Inc.
KWS
Dec 23, 2015K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
Ascension Orthopedics
KWS
Dec 15, 2015K152267Remedy® Shoulder Spacer
Osteoremedies, LLC
KWS
Nov 23, 2015K153115Arthrex Univers Apex, Size 5 Stem
Arthrex, Inc.
KWS
Oct 5, 2015K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
Custom Orthopaedic Solutions
KWS
Sep 24, 2015K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
Tornier S.A.S., FR
KWS
May 28, 2015K143256SMR Modular Glenoid
Lima Corporate S.P.A., IT
KWS
Apr 23, 2015K150583Aequalis PerFORM+ Shoulder System
Tornier, Inc.
KWS
Apr 8, 2015K143374BLUEPRINT Patient Specific Instrumentation
Tornier S.A.S., FR
KWS
Nov 24, 2014K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
Zimmer GmbH, CH
KWS
Nov 24, 2014K142072GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
Custom Orthopaedic Solutions, Inc.
KWS
Nov 14, 2014K142413TITAN Modular Total Shoulder System
Ascension Orthopedics
KWS
Jun 3, 2014K133349SMR TT METAL BACK GLENOID
Lima Corporate S.P.A.
KWS
Apr 3, 2014K133834DEPUY GLOBAL UNITE SHOULDER SYSTEM
Depuy(Ireland), IE
KWS
Feb 11, 2014K140063EQUINOXE EXTRA SHORT HUMERAL HEAD
Exactech, Inc.
KWS
Feb 7, 2014K133462DUOCENTRIC REVERSED SHOULDER PROSTHESIS
Aston Medical
KWS
Oct 29, 2013K130048REVERSE SHOULDER PROSTHESIS MONOBLOCK
Encore Medical L.P.
KWS
Sep 27, 2013K131633ARTHREX UNIVERS APEX
Arthrex, Inc.
KWS
Sep 27, 2013K131559MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
Materialise NV, BE
KWS
Aug 28, 2013K131277SEVIIN FRACTURE SHOULDER
Ingen Orthopedics, LLC
KWS
Aug 20, 2013K131129CAS PSI SHOULDER
Zimmer Cas
KWS
Jun 18, 2013K130050TITAN REVERSE SHOULDER SYSTEM
Ascension Orthopedic
KWS
Jun 12, 2013K130642SMR 3-PEGS GLENOIDS
Lima Corporate S.P.A.
KWS
Jun 7, 2013K131112LIMACORPORATE SMR CTA HUMERAL HEADS
Lima Corporate S.P.A.
KWS
May 31, 2013K130129UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
Arthrex, Inc.
KWS
Apr 5, 2013K123122GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
Cleveland Clinic
KWS
Jan 23, 2013K123982TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
Encore Medical L.P.
KWS
Jan 8, 2013K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Tornier S.A.S.
KWS
Nov 20, 2012K121220EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
Exactech, Inc.
KWS
Jun 20, 2012K121493ASCEND SHOULDER SYSTEM
Tornier, Inc.
KWS
Apr 13, 2012K120794ASCEND SHOULDER SYSTEM
Tornier, Inc.
KWS
Apr 11, 2012K112438TITAN MODULAR TOTAL SHOULDER SYSTEM
Ascension Orthopedic
KWS
Mar 9, 2012K113413ASCEND SHOULDER SYSTEM
Tornier, Inc.
KWS
Mar 8, 2012K120044ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
Arthrex, Inc.
KWS
Jan 5, 2012K113012PROMOS MODULAR SHOULDER SYSTEM
Smith & Nephew, Inc.
KWS
Dec 8, 2011K113309EXACTECH EQUINOXE CAGE GLENOIDS
Exactech, Inc.
KWS
Nov 3, 2011K111902AEQUALIS SHOULDER SYSTEM
Tornier, FR
KWS
Jul 28, 2011K111212SMR SHOULDER SYSTEM- REVISION STEMS
Lima Corporate S.P.A.
KWS
Jul 15, 2011K110847SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
Lima Corporate S.P.A.
KWS
Jul 5, 2011K111596TOTAL SHOULDER SYSTEM
Shoulder Innovations, LLC
KWS
Jun 8, 2011K111379EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
Exactech, Inc.
KWS
May 24, 2011K110905TOTAL SHOULDER SYSTEM
Shoulder Innovations, LLC
KWS
May 5, 2011K103835REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
Howmedica Osteonics Corp.
KWS
Apr 27, 2011K110865AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
Tornier, Inc.
KWS
Jan 31, 2011K102924AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
Tornier, Inc.
KWS
Jan 24, 2011K102670TOTAL SHOULDER SYSTEM
Shoulder Innovations, LLC
KWS
Dec 22, 2010K103466ARTHREX UNIVERS II SHOULDER PROSTHESIS
Arthrex, Inc.
KWS

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