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
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+5K121493Ascend Shoulder SystemTornier, Inc.201297—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+6K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+6K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K243248Inhance Intact™Depuy Ireland UC20240—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—