510(k) Report

Devices descending from K000538

172 later devices reach Mallory/Head Lateralized Press-Fit Femoral through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+8K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+8K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+8K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+8K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+8K241472Icona Hip StemCorin U.S.A. Limited20241—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.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—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+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—
+8K201315PERFORM Humeral System – StemTornier, Inc.2020111
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+9K261576Icona Hip StemCorin, Ltd.20260—
+9K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+9K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+9K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+9K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+9K210678implaFit® hip stemsImplantcast GmbH20223—
+9K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+9K221104Actera™ hip systemConformis, Inc.202211
+9K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+10K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+10K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+10K252401implaFit® short stemsImplantcast GmbH20260—
+10K252067Velora Acetabular SystemRestor3D, Inc.20250—
+10K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+10K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+10K232371Actinia® hip stemsImplantcast GmbH20231—
+10K231178ACTERA™ hip systemConformis, Inc.20230—
+11K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+11K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+11K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—