510(k) Report

Devices descending from K992119

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+1K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+1K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+1K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+1K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc.20042188
+1K021478Delta ShoulderDepuy, Inc.2003338—
+1K032507Interlok Bio-Modular Humeral StemsBiomet, Inc.2003123—
+1K030710Bio-Modular Shoulder SystemBiomet, Inc.20032531
+1K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc.20021462
+1K012377Oxford Modular Shoulder Prosthesis, 192.XXX Catalogue SeriesCorin USA20020—
+1K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.20011421
+1K010657Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc.2001136—
+2K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+2K191814Alliance GlenoidZimmer, Inc.20194—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+2K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+2K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+2K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+2K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+2K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+2K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+2K113413Ascend Shoulder SystemTornier, Inc.2012105—
+2K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+2K103251Duocentric ReversedAston Medical20117—
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+2K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+2K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+2K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+2K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+2K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+2K062661Aequalis Resurfacing HeadTornier200616—
+2K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc.2006121—
+2K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+2K061439Aequalis Reversed ProsthesisTornier2006199—
+2K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+2K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+2K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+2K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.200561
+2K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+2K050761Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMZimmer, Inc.200506
+2K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+2K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051761
+2K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059—
+2K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+2K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+2K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+2K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+2K032895BI-Angular Shoulder SystemBiomet, Inc.200310—
+2K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003141—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+3K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+3K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+3K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+3K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—