510(k) Report

Devices descending from K123814

32 later devices reach Humelock II Cemented Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+1K163669Humeris ShoulderFx Solutions201720—
+1K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+1K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+2K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+2K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+2K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+2K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+2K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+2K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+2K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+2K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+2K162455Humelock Reversed ShoulderFx Solutions201717—
+3K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—