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
+3K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+3K181693SMS Femoral StemMedacta International S.A.20184—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K170072Fitmore® Hip StemZimmer GmbH20170—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+3K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+3K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+3K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+3K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+3K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K123392Avenir Muller StemZimmer GmbH2013414
+3K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K121563Corin Trifit TS HipCorin USA2012101
+3K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+3K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH201101
+3K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+3K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+3K093472Trinity Acetabular SystemCorin USA20101171
+3K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+3K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083—
+3K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+3K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc.20073Class I
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K203041SMS Cementless StemMedacta International S.A.20201—
+4K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—