510(k) Report

Devices descending from K974093

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+1K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+1K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+1K072888Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and…Encore Medical L.P.2008103—
+1K072154Foundation (FMP) Porous Coated Spiked Acetabular SystemEncore Medical L.P.2007611
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+2K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+2K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+2K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K182099Delta TT ProLima Corporate S.P.A.20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+2K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.2011741
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K172651FMP Extended LinersEncore Medical L.P.20173—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K140830Exprt Revision KneeEncore Medical L.P.201471
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+4K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+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—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+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—
+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—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+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—