510(k) Report

Devices descending from K060209

257 later devices reach Aequalis Shoulder Fracture System & Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K113413Ascend Shoulder SystemTornier, Inc.2012105—
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K103251Duocentric ReversedAston Medical20117—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K260556Veritas Shoulder SystemRestor3D20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K243509Archer PSI System3D-Side20250—
+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—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+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—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+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—
+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—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+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—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+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
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+5K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+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—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—