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
+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—
+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
+1K060635Consensus Acetabular Shell SystemHayes Medical, Inc.200669—
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+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
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+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—
+2K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421—
+2K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+2K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.2011741
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+3K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+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—
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+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—
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+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—
+3K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+3K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+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—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+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—
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+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
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346