510(k) Report

Devices descending from K052718

186 later devices reach V40 Biolox Delta Ceramic Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K23402522.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+1K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+1K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+1K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2007141
+2K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+2K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+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—
+2K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+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
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+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—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+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—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+3K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+3K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K131518Mectacer Biolox Option HeadsMedacta International20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131647Trinity Acetabular SystemCorin USA201322—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+4K130128Trinity Acetabular SystemCorin Medical201317—
+4K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+4K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+4K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+4K111911Corin Optimom Modular HeadCorin USA201162—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—