510(k) Report

Devices descending from K001448

150 later devices reach Trident Acetabular Shells: PS-HA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+1K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+1K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+1K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+2K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+2K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+2K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+2K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+2K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+2K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+2K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+2K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+2K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+2K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+2K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+3K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+3K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+3K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+3K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+3K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+3K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+3K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+3K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+3K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+3K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+3K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K083312Minihip StemCorin USA201015—
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+4K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K131986Corin Minihip StemCorin USA20133—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K103518Trinity Acetabular SystemCorin USA20118—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—