510(k) Report

Devices descending from K070885

54 later devices reach Universal Taper Delta Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K110290Exeter Hip StemHowmedica Osteonics Corp.2011371
+1K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2007141
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+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—
+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—
+2K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+2K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K073567Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH200871
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+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—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+3K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K261576Icona Hip StemCorin, Ltd.20260—