510(k) Report

Devices descending from K955731

242 later devices reach Osteonics Shoulder Humeral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+7K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+7K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+7K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+7K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+7K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+8K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+8K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+8K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+8K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+8K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+8K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+8K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+8K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+8K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+8K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+8K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+8K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+8K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+8K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+8K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+9K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+9K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+9K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+9K201315PERFORM Humeral System – StemTornier, Inc.2020111
+9K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+9K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+9K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+9K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+10K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+10K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+10K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+10K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+11K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501