510(k) Report

Devices descending from K043077

258 later devices reach Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+4K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+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—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K120794Ascend Shoulder SystemTornier, Inc.201298—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K243509Archer PSI System3D-Side20250—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K163669Humeris ShoulderFx Solutions201720—
+5K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—