510(k) Report

Devices descending from K910988

303 later devices reach Osteonics Ion Implanted Femoral Bearing Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+5K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+5K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+5K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+5K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+5K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+5K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+5K093472Trinity Acetabular SystemCorin USA20101171
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K083312Minihip StemCorin USA201015—
+5K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+5K081023Evolis Total Knee SystemMedacta International S.A.2008781
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+6K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+6K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+6K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+6K142069GMK ExtensionMedacta International20144—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K131986Corin Minihip StemCorin USA20133—
+6K131647Trinity Acetabular SystemCorin USA201322—
+6K131310GMK Full PE Tibial ComponentsMedacta International20132—
+6K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+6K130128Trinity Acetabular SystemCorin Medical201317—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+6K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+6K121416GMK SphereMedacta International201220—
+6K120790GMK - Line ExtensionMedacta International201211—
+6K113571GMK Resufacing Patella Size 4Medacta International201223—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+6K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+6K111283GMK Revision Hybrid LinersMedacta International20110—
+6K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+6K103518Trinity Acetabular SystemCorin USA20118—
+6K090988GMK Total Knee SystemMedacta International S.A.2009521
+6K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+7K262057GMK ExtensionMedacta International SA20260—
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K250450Coated hip implantsMedacta International S.A.20250—
+7K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—