510(k) Report

Devices descending from K973302

248 later devices reach Foundation Porous Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+5K172251UTS StemUnited Orthopedic Corporation20171—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172—
+5K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+5K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+5K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+5K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+5K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K123550Utf Stem, ReducedUnited Orthopedic Corporation20134—
+5K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+5K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+5K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+5K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+5K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+5K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+5K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+5K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+5K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc.20106530
+5K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+6K261453G7® Acetabular SystemZimmer Biomet20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, 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—
+6K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+6K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+6K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+6K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+6K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+6K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+6K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+6K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+7K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K254003JARVIS Metaphyseal StemFH Industrie20260—
+7K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+7K250450Coated hip implantsMedacta International S.A.20250—
+7K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+7K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—