510(k) Report

Devices descending from K001471

81 later devices reach The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular2006794
+1K052888Porous Titanium Acetabular AugmentsBiomet Manufacturing Corp200554—
+2K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.20250—
+2K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+2K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+2K102019Restoration Acetabular Wedge AugmentsHowmedica Osteonics2011211
+2K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K212746ATTUNE Revision ConesDepuy Ireland UC20221—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+3K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics2015401
+3K123924Depuy Gription TF 5.5MM Sterile Locking ScrewsDepuy Orthopaedics20137—
+4K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K230295ATTUNE® Revision ConesDepuy Ireland UC20230—
+4K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+4K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+4K200653AMF Revision TT ConesLima Corporate S.P.A.20203—
+4K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+4K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+4K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+4K153595Optetrak Logic Metaphyseal ConesExactech, Inc.20168—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+5K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis)20241—
+5K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K234011AMF TT ConesLima Corporate S.P.A.20240—
+5K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+5K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+5K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+5K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+5K200113LINK TrabecuLink Tibial ConesWaldemar Link GmbH & Co. KG20201—
+5K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+5K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+5K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+5K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+5K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+6K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+6K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+6K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+6K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+6K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+6K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG20200—
+7K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+7K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—