510(k) Report

Devices descending from K955033

328 later devices reach Rim Flare Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+6K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+6K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+6K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+6K131518Mectacer Biolox Option HeadsMedacta International20130—
+6K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+6K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+6K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+6K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+6K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+6K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+6K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+6K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+6K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+6K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+6K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+6K093472Trinity Acetabular SystemCorin USA20101171
+6K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+6K083312Minihip StemCorin USA201015—
+6K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+6K081023Evolis Total Knee SystemMedacta International S.A.2008781
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+7K243444Bioceram Azul® HeadKyocera Corporation20240—
+7K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+7K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+7K211866Bencox THR SystemCorentec Co., Ltd.20210—
+7K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+7K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+7K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+7K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+7K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+7K170473C2 femoral stemLima Corporate S.P.A.20170—
+7K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+7K160011H-Max S stemLima Corporate S.P.A.20161—
+7K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+7K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+7K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+7K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+7K142069GMK ExtensionMedacta International20144—
+7K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+7K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+7K131986Corin Minihip StemCorin USA20133—
+7K131647Trinity Acetabular SystemCorin USA201322—
+7K131310GMK Full PE Tibial ComponentsMedacta International20132—
+7K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+7K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+7K130128Trinity Acetabular SystemCorin Medical201317—
+7K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+7K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+7K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+7K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+7K121563Corin Trifit TS HipCorin USA2012101
+7K121416GMK SphereMedacta International201220—
+7K120790GMK - Line ExtensionMedacta International201211—
+7K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+7K113571GMK Resufacing Patella Size 4Medacta International201223—
+7K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+7K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+7K111911Corin Optimom Modular HeadCorin USA201162—
+7K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+7K111283GMK Revision Hybrid LinersMedacta International20110—
+7K103518Trinity Acetabular SystemCorin USA20118—
+7K090988GMK Total Knee SystemMedacta International S.A.2009521
+7K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+8K262057GMK ExtensionMedacta International SA20260—
+8K261576Icona Hip StemCorin, Ltd.20260—
+8K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+8K250450Coated hip implantsMedacta International S.A.20250—
+8K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+8K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+8K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+8K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+8K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+8K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+8K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+8K211664GMK Sphere RevisionMedacta International S.A.20210—
+8K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+8K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+8K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+8K210062Mectaplug PE IIMedacta International S.A.20210—
+8K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+8K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—