510(k) Report

Devices descending from K042871

80 later devices reach Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3… through their predicates, nearest generation first.

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