510(k) Report

Devices descending from K001277

213 later devices reach Triflange Acetabular Cup System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040383Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc.20042—
+1K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003207—
+1K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC20230—
+2K201348DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd.20221—
+2K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+2K192919Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.20196—
+2K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+2K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+2K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+2K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.201291
+2K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+2K042344Excia Total Hip SystemAesculap, Inc.200519810
+3K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K251166Mfinity Femoral SystemMedacta International S.A.20250—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K251052Trivicta® Hip StemOrtho Development Corp.20250—
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+3K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+3K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+3K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+3K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+3K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+3K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+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—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+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—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—