510(k) Report

Devices descending from K983502

72 later devices reach Osteonics Secur-Fit AD Generation II Acetabular Component System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+1K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.200069—
+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
+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—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+2K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+2K041940Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral HeadsHowmedica Osteonics Corp.200518—
+2K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+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—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+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—
+3K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+4K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+4K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+4K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+4K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+5K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+6K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+7K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+7K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+8K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+8K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+8K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+8K163577Ecofit® Hip SystemImplantcast GmbH201791
+8K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+9K252451EPORE® XO cup systemImplantcast GmbH20260—
+9K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+9K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+9K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+9K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+9K210678implaFit® hip stemsImplantcast GmbH20223—
+9K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+9K203420EcoFit® Hip SystemImplantcast GmbH20214—
+9K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+9K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+9K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+10K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+10K252401implaFit® short stemsImplantcast GmbH20260—
+10K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+10K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+10K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+10K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+10K232371Actinia® hip stemsImplantcast GmbH20231—
+10K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—