510(k) Report

Devices descending from K993601

299 later devices reach Howmedica Osteonics Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+5K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+5K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+5K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+5K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142069GMK ExtensionMedacta International20144—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K131986Corin Minihip StemCorin USA20133—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K131310GMK Full PE Tibial ComponentsMedacta International20132—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K121563Corin Trifit TS HipCorin USA2012101
+5K121416GMK SphereMedacta International201220—
+5K120790GMK - Line ExtensionMedacta International201211—
+5K113571GMK Resufacing Patella Size 4Medacta International201223—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K111283GMK Revision Hybrid LinersMedacta International20110—
+5K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K090988GMK Total Knee SystemMedacta International S.A.2009521
+5K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+6K262057GMK ExtensionMedacta International SA20260—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K162035GMK SphereMedacta International S.A.201710—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+6K140826GMK Sphere ExtensionMedacta International201417—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K133630GMK Short StemMedacta International20131—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K123721GMK Revision ExtensionMedacta International20133—
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K122232GMK NarrowMedacta International20128—
+6K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+6K111911Corin Optimom Modular HeadCorin USA201162—
+6K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+6K103721Mpact Acetabular SystemMedacta International201121—
+6K103352Versafitcup CC TrioMedacta International20114—
+6K102437GMK Revision Knee SystemMedacta International S.A.201034—
+6K093806Myknee Cutting BlocksMedacta International S.A.201016—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K241461Mpact Constrained LinerMedacta International S.A.20251—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—