510(k) Report

Devices descending from K022958

162 later devices reach Total Hip Femoral Heads and Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+1K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+1K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+1K081566Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc.20088—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+2K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+2K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K132158Novohip Total Hip SystemNovosource, Inc.201461
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+2K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+2K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+2K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+2K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+2K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+3K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K131647Trinity Acetabular SystemCorin USA201322—
+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—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K131986Corin Minihip StemCorin USA20133—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—