510(k) Report

Devices descending from K030710

253 later devices reach Bio-Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191814Alliance GlenoidZimmer, Inc.20194—
+1K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+1K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+1K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+1K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+1K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+1K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+1K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+1K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+1K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+1K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+1K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+1K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+1K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+1K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.200561
+1K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051761
+1K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059—
+1K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+1K032895BI-Angular Shoulder SystemBiomet, Inc.200310—
+2K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+2K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+2K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+2K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+2K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+2K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+2K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+2K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+2K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+2K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+2K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+2K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+2K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+2K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+2K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+2K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+2K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K131633Arthrex Univers ApexArthrex, Inc.20134—
+2K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+2K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+2K120794Ascend Shoulder SystemTornier, Inc.201298—
+2K113413Ascend Shoulder SystemTornier, Inc.2012105—
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+2K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+2K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+2K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+2K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+3K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+3K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+3K240876Identity Shoulder SystemZimmer, Inc.20241—
+3K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+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—
+3K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+3K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—