510(k) Report

Devices descending from K041339

259 later devices reach Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K113413Ascend Shoulder SystemTornier, Inc.2012105—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K243509Archer PSI System3D-Side20250—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+5K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+5K120794Ascend Shoulder SystemTornier, Inc.201298—
+6K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—