510(k) Report

Devices descending from K010171

239 later devices reach Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211
+8K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+9K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+9K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+9K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—