510(k) Report

Devices descending from K022077

298 later devices reach 36MM V40 Femoral Head Components (Lfit and Non-Lfit) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+4K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K142069GMK ExtensionMedacta International20144—
+4K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K131986Corin Minihip StemCorin USA20133—
+4K131647Trinity Acetabular SystemCorin USA201322—
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+4K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+4K130128Trinity Acetabular SystemCorin Medical201317—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+4K121563Corin Trifit TS HipCorin USA2012101
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+5K262057GMK ExtensionMedacta International SA20260—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+5K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K211664GMK Sphere RevisionMedacta International S.A.20210—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K162035GMK SphereMedacta International S.A.201710—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133630GMK Short StemMedacta International20131—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K123721GMK Revision ExtensionMedacta International20133—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K122232GMK NarrowMedacta International20128—
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K111911Corin Optimom Modular HeadCorin USA201162—
+5K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K102437GMK Revision Knee SystemMedacta International S.A.201034—
+5K093806Myknee Cutting BlocksMedacta International S.A.201016—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—