510(k) Report

Devices descending from K003391

174 later devices reach Osteonics Alumina C-Taper Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K041940Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral HeadsHowmedica Osteonics Corp.200518—
+1K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc.20021621
+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—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+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—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+2K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+2K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+2K081566Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc.20088—
+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—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+3K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K132158Novohip Total Hip SystemNovosource, Inc.201461
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+3K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+3K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+3K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+3K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+3K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+4K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+4K131518Mectacer Biolox Option HeadsMedacta International20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+5K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K111911Corin Optimom Modular HeadCorin USA201162—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—