510(k) Report

Devices descending from K023102

306 later devices reach Accolade TMZF Plus HA 127 Size 0 Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K120578Accolade II Hip StemHowmedica Osteonics2012461
+1K103479Novel Tapered Hip StemStryker Corp.201153—
+1K043079Bicontact Hip System with U-CapAesculap2004166—
+1K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+2K211703Insignia Hip StemStryker Orthopaedics20217—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+2K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+2K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+2K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+2K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+2K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+2K093472Trinity Acetabular SystemCorin USA20101171
+2K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+2K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+2K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+2K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+2K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+2K042344Excia Total Hip SystemAesculap, Inc.200519810
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+3K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+3K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K170845MiniMAXMedacta International S.A.201771
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K142761Corin TaperFit Hip StemCorin USA201541
+3K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+3K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K130128Trinity Acetabular SystemCorin Medical201317—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K121563Corin Trifit TS HipCorin USA2012101
+3K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+3K103518Trinity Acetabular SystemCorin USA20118—
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K081023Evolis Total Knee SystemMedacta International S.A.2008781
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—