510(k) Report

Devices descending from K994366

76 later devices reach TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+1K120578Accolade II Hip StemHowmedica Osteonics2012461
+1K103479Novel Tapered Hip StemStryker Corp.201153—
+1K052542Accolade RPS Hip StemStryker Orthopaedics20050—
+1K051741Accolade HFX Femoral StemStryker Orthopaedics200518—
+2K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+2K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+2K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+2K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+2K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+2K211703Insignia Hip StemStryker Orthopaedics20217—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+2K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+2K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+2K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+2K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+2K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+2K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+2K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+2K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+3K170845MiniMAXMedacta International S.A.201771
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+4K192352MiniMAXMedacta International S.A.20192—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+5K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K201673SMS Cementless StemMedacta International S.A.20203—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—