510(k) Report

Devices descending from K974093

145 later devices reach Foundation Porous Coated Hemispherical Shell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+6K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+7K250644MSS - Monobloc stemMedacta International S.A.202611
+7K254003JARVIS Metaphyseal StemFH Industrie20260—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+7K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243248Inhance Intact™Depuy Ireland UC20240—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+9K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+9K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+9K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—