510(k) Report

Devices descending from K790987

271 later devices reach Zimmer R Total Shoulder II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+6K141345Aequalis FX2Tornier S.A.S.201411
+6K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K141006RSP Humeral Socket InsertDjo Global2014212
+6K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+6K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+6K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+6K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+7K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+7K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+7K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+7K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+7K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+7K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+7K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+7K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+7K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+7K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+7K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+7K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+7K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+7K152966Aequalis Fx2Tornier S.A.S.201601
+7K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+7K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+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—
+8K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+8K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+8K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+8K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+8K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+8K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+9K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+10K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—