510(k) Report

Devices descending from K081171

61 later devices reach Tritanium Acetabular Shell System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+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—
+1K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+1K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+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
+2K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+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—
+3K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—