510(k) Report

Devices descending from K103835

43 later devices reach Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+1K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+2K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+3K163669Humeris ShoulderFx Solutions201720—
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+4K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+4K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+5K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+5K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—