510(k) Report

Devices descending from K951671

154 later devices reach Osteonics Restoration Monolithic II Slotted Hip Stem Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972893Partnership Revision Femoral StemsHowmedica Corp.1997153—
+2K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200210137
+2K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.200069—
+2K983404Type 3 Femoral ComponentsHowmedica Corp.19981021
+2K980813Reliance Long Stem Femoral ComponentsHowmedica, Inc.19980—
+2K980239Partnership Calcar Femoral ComponentsHowmedica, Inc.19980—
+3K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20218—
+3K193233Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)20200—
+3K120578Accolade II Hip StemHowmedica Osteonics2012461
+3K103479Novel Tapered Hip StemStryker Corp.201153—
+3K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+3K022549Restoration Modular SystemHowmedica Osteonics Corp.2002543
+3K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+4K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K211703Insignia Hip StemStryker Orthopaedics20217—
+4K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+4K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+4K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+4K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+4K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+4K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+4K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+4K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+4K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+4K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+4K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+4K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+4K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+4K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+5K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+5K220405Amis K LongMedacta International S.A.20220—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+5K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+5K190100USTAR II SystemUnited Orthopedic Corporation201925
+5K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+5K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+5K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+5K170845MiniMAXMedacta International S.A.201771
+5K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+5K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+5K151739Revision Femoral StemLima Corporate S.P.A.20157—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+5K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+5K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+5K113556Wagner Cone Prosthesis SystemZimmer GmbH201291
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+6K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+6K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+6K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+6K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+6K192352MiniMAXMedacta International S.A.20192—
+6K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+6K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH20191—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K181693SMS Femoral StemMedacta International S.A.20184—
+6K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+6K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—