510(k) Report

Devices descending from K010170

297 later devices reach Trident Porous Titanium Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+4K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+4K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+4K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+4K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+4K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K083312Minihip StemCorin USA201015—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081023Evolis Total Knee SystemMedacta International S.A.2008781
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+5K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142069GMK ExtensionMedacta International20144—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K131986Corin Minihip StemCorin USA20133—
+5K131310GMK Full PE Tibial ComponentsMedacta International20132—
+5K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+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—
+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—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+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—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—