510(k) Report

Devices descending from K962315

335 later devices reach Select Shoulder Cocr Humeral Stem Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+7K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+7K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+7K163669Humeris ShoulderFx Solutions201720—
+7K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+7K121493Ascend Shoulder SystemTornier, Inc.201297—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+8K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+8K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+8K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+8K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+8K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+8K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+8K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+9K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+9K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+9K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+9K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+9K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+9K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+10K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—