510(k) Report

Devices descending from K974095

191 later devices reach Foundation Porous Coated Flared Rim Shell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+5K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+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—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+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—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+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—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+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—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+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—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+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—