510(k) Report

Devices descending from K053274

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501