510(k) Report

Devices descending from K042091

345 later devices reach Biolox Delta Ceramic Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+7K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+7K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+8K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K211703Insignia Hip StemStryker Orthopaedics20217—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+9K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+9K221104Actera™ hip systemConformis, Inc.202211
+10K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+10K231178ACTERA™ hip systemConformis, Inc.20230—
+11K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+11K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+11K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—