510(k) Report

Devices descending from K952928

393 later devices reach Aequalis Shoulder System for Total & Hemishoulder Applications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+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—
+5K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+5K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+5K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+5K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+5K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213856Identity Shoulder SystemZimmer, Inc.20224—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+5K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+5K202338SpaceFlex ShoulderG21, S.R.L.20211—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+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
+5K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+5K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+5K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+5K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+5K121493Ascend Shoulder SystemTornier, Inc.201297—
+6K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K250848Identity Shoulder SystemZimmer, Inc.20250—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—