510(k) Report

Devices descending from K041066

303 later devices reach Encore Reverse Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+4K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+4K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+4K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+4K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+4K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+4K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+4K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K243509Archer PSI System3D-Side20250—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+5K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+9K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—