510(k) Report

Devices descending from K053274

239 later devices reach Anatomical Shoulder Inverse/Reverse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+1K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+1K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+1K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+1K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+1K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+1K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+1K103251Duocentric ReversedAston Medical20117—
+1K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+1K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+1K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+1K071948Aequalis Reversed AdapterTornier2007178—
+1K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+2K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+2K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+2K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+2K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+2K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+2K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+2K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+2K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+2K193099Anatomical Shoulder SystemZimmer GmbH20201—
+2K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+2K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+2K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+2K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+2K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+2K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+2K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+2K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+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
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K163669Humeris ShoulderFx Solutions201720—
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K162455Humelock Reversed ShoulderFx Solutions201717—
+2K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+2K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+2K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+2K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+2K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+2K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+2K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+2K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+2K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+2K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+2K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+2K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+2K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+2K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+3K260556Veritas Shoulder SystemRestor3D20260—
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+3K241043Augment Off-Axis Instrument SystemFix Surgical202415