510(k) Report

Devices descending from K983509

327 later devices reach Inter-OP Acetabular System - Durasul Acetabular Insert through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+1K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc.20003263
+2K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+2K211047CoCr HeadZimmer GmbH20230—
+2K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp.2006542
+2K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002285—
+2K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc.20021621
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+3K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K110290Exeter Hip StemHowmedica Osteonics Corp.2011371
+3K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+3K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+3K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+3K081566Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc.20088—
+3K042344Excia Total Hip SystemAesculap, Inc.200519810
+3K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+4K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+4K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+4K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+4K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+4K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K132158Novohip Total Hip SystemNovosource, Inc.201461
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+4K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+4K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+4K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+4K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+4K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+4K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+4K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+4K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+4K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+4K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+4K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+4K043079Bicontact Hip System with U-CapAesculap2004166—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+5K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+5K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+5K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+5K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—