510(k) Report

Devices descending from K921301

383 later devices reach Taperloc Femoral Stem and Universal Acetabular Com through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K170845MiniMAXMedacta International S.A.201771
+4K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+4K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+4K131647Trinity Acetabular SystemCorin USA201322—
+4K131884Avenir Cemented Hip StemZimmer GmbH20131—
+4K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+4K130128Trinity Acetabular SystemCorin Medical201317—
+4K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+4K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K083312Minihip StemCorin USA201015—
+4K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+4K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+4K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+4K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+5K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K233476Z1 Hip SystemOrchard Medical Development202421
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+5K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+5K192352MiniMAXMedacta International S.A.20192—
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K171156OMNI Anseris Hip StemOmnilife Science20170—
+5K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+5K162775Legion Cone SystemSmith & Nephew, Inc.201752
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+5K131986Corin Minihip StemCorin USA20133—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+5K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+5K112682Metha Hip SystemAesculap Implant Systems, LLC20122—