510(k) Report

Devices descending from K961260

176 later devices reach Kirschner Sholders with Titanium Plasma Spray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+1K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc.20021462
+1K992525Acumed Modular Shoulder SystemAcu Med, Inc.2000761
+2K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+2K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+2K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+2K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+2K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+2K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+2K131633Arthrex Univers ApexArthrex, Inc.20134—
+2K120794Ascend Shoulder SystemTornier, Inc.201298—
+2K111097Humelock Cemented Shoulder ProsthesisFx Solutions2011342
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.201138—
+2K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.2010372
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+2K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+3K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+3K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K213856Identity Shoulder SystemZimmer, Inc.20224—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+3K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K161476SMR Shoulder SystemLima Corporate S.P.A.20161—
+3K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K121493Ascend Shoulder SystemTornier, Inc.201297—
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+3K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K250848Identity Shoulder SystemZimmer, Inc.20250—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K163669Humeris ShoulderFx Solutions201720—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+4K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+4K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K131112Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A.20130—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—