510(k) Report

Devices descending from K991990

105 later devices reach Tri-Polar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Serf2011275
+1K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+1K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+1K070278Polarcup Dual Mobility SystemPlus Orthopedics AG200778—
+1K051569Ringloc BI-Polar Acetabular ComponentBiomet, Inc.2005254
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+2K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+2K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+2K191831MobiliT CupCorin U.S.A. Limited20203—
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K181744BI-MENTUM dual mobility systemSerf201810—
+2K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+2K171934Birmingham Hip (BH) Dual Mobility InsertSmith & Nephew, Inc.20179—
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+2K110135Polarcup Dual Mobility SystemSmith & Nephew, Inc.201114—
+2K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+2K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+2K083116Versafit Cup Double Mobility SystemMedacta International S.A.2009592
+2K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K231522EMPHASYS™ Dual Mobility SystemDepuy Ireland UC20240—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+3K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+3K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+3K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K203532BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC20216—
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K131458Mpact DM Liner ConverterMedacta International20133—
+3K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+3K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc.20125—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103352Versafitcup CC TrioMedacta International20114—
+3K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K211891DM Converter - TiN coatedMedacta International S.A.20220—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111145Endo HeadMedacta International20110—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+5K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—