510(k) Report

Devices descending from K971854

216 later devices reach Osteolock Acetabular Shell System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.200069—
+1K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000150—
+1K993874Bofor Revision CoupPlus Orthopedics200065—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+2K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+2K011719Plus Cancellous Bone ScrewsPlus Orthopedics200163—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+3K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+3K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+3K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+3K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+4K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+4K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+4K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+4K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+4K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+4K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+4K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+4K103721Mpact Acetabular SystemMedacta International201121—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K103352Versafitcup CC TrioMedacta International20114—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K083312Minihip StemCorin USA201015—
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+5K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—