510(k) Report

Devices descending from K920362

353 later devices reach 3M Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+6K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+6K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+6K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K202338SpaceFlex ShoulderG21, S.R.L.20211—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+6K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+6K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+6K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+6K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+6K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+6K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+6K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+6K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+6K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+6K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+6K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+6K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+6K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+6K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+6K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+6K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+6K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+6K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+6K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+6K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+6K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K120794Ascend Shoulder SystemTornier, Inc.201298—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+7K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+7K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+7K243509Archer PSI System3D-Side20250—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+7K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+7K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+7K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+7K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+7K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+7K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+7K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+7K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+7K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+7K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+7K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+7K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+7K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+7K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+7K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+7K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—