510(k) Report

Devices descending from K950521

45 later devices reach Osteonics All Polyethylene Glenoid Shoulder Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+1K103104Special Orthopaedic Solutions Glenoid Shoulder ComponentHowmedica Osteonics Corp.20100—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K163669Humeris ShoulderFx Solutions201720—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—