510(k) Report

Devices descending from K940537

281 later devices reach Kirschner (R) Modular II-C (TM) Total Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982981New Zimmer Shoulder SystemZimmer, Inc.19982351
+1K961260Kirschner Sholders with Titanium Plasma SprayBiomet, Inc.1997176—
+1K961571Cocr BI-Angular Humeral ComponentBiomet, Inc.1996147—
+2K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+2K110791Bigliani / Flatow (R) the Complete Shoulder SolutionZimmer, Inc.201101
+2K111596Total Shoulder SystemShoulder Innovations, LLC201115—
+2K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+2K102670Total Shoulder SystemShoulder Innovations, LLC201118—
+2K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+2K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc.20042188
+2K030344Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc.20030—
+2K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc.20021462
+2K992525Acumed Modular Shoulder SystemAcu Med, Inc.2000761
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+3K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+3K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+3K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+3K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+3K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K131633Arthrex Univers ApexArthrex, Inc.20134—
+3K120794Ascend Shoulder SystemTornier, Inc.201298—
+3K111097Humelock Cemented Shoulder ProsthesisFx Solutions2011342
+3K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.201138—
+3K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.2010372
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050761Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMZimmer, Inc.200506
+3K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+3K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+4K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K213856Identity Shoulder SystemZimmer, Inc.20224—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+4K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K161476SMR Shoulder SystemLima Corporate S.P.A.20161—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+4K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+4K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+4K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+4K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+4K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+4K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+4K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+4K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+4K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—