510(k) Report

Devices descending from K920362

353 later devices reach 3M Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+7K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+7K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+7K163669Humeris ShoulderFx Solutions201720—
+7K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+7K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+7K121493Ascend Shoulder SystemTornier, Inc.201297—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+8K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+8K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+8K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+8K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+8K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+8K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+8K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+8K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+8K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+8K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+9K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+9K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+9K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+9K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+9K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+9K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+9K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+9K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+9K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+9K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+9K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+10K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+10K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+10K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+11K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+12K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—