510(k) Report

Devices descending from K983382

153 later devices reach Osteonics HA Generation II Acetabular Component System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+1K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+1K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+1K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+1K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+1K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+1K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000150—
+1K991952Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene InsertsHowmedica Osteonics Corp.199920—
+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
+2K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+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
+2K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+2K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+2K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+2K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+2K041940Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral HeadsHowmedica Osteonics Corp.200518—
+2K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+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—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+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—
+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—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+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—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K131986Corin Minihip StemCorin USA20133—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K103518Trinity Acetabular SystemCorin USA20118—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+6K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+7K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—