510(k) Report

Devices descending from K903362

228 later devices reach Osteolock (TM) Acetabular Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp.199918—
+1K981201Osteolock Acetabular CupHowmedica Corp.199866—
+1K971854Osteolock Acetabular Shell SystemHowmedica Corp.1997216—
+2K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+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—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.200069—
+2K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000150—
+2K993874Bofor Revision CoupPlus Orthopedics200065—
+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—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+3K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+3K011719Plus Cancellous Bone ScrewsPlus Orthopedics200163—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+4K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+4K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+4K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+4K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+4K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+4K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+5K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+5K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+5K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+5K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+5K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K083312Minihip StemCorin USA201015—
+5K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+5K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+5K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+5K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+5K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+5K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—