510(k) Report

Devices descending from K040487

85 later devices reach Trabecular Metal Knee System Augments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120990Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…Zimmer Trabecular Metal Technology201271
+1K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc.201111—
+1K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619—
+1K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular200674—
+2K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG20200—
+2K200653AMF Revision TT ConesLima Corporate S.P.A.20203—
+2K2000753DMetal Diaphyseal Femoral ConesMedacta International S.A.20200—
+2K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+2K182085Balanced Knee Revision System Trabecular Tibial Cone AugmentsOrtho Development Corporation20180—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K162775Legion Cone SystemSmith & Nephew, Inc.201752
+2K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics2015401
+2K141840Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone BroachZimmer, Inc.20140—
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053—
+2K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+2K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074—
+3K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+3K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+3K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis)20241—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.20240—
+3K234011AMF TT ConesLima Corporate S.P.A.20240—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K212746ATTUNE Revision ConesDepuy Ireland UC20221—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+3K1701493DMetal Tibial ConesMedacta International S.A.20170—
+3K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+3K153595Optetrak Logic Metaphyseal ConesExactech, Inc.20168—
+3K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+3K123924Depuy Gription TF 5.5MM Sterile Locking ScrewsDepuy Orthopaedics20137—
+3K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+4K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.20250—
+4K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+4K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+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—
+4K230295ATTUNE® Revision ConesDepuy Ireland UC20230—
+4K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+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—
+4K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+4K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+4K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+5K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+5K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+5K153437Apex Revision Knee SystemOmnilife Science201541
+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—
+6K163332Apex Revision Knee SystemOmnilife Science20173—
+7K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+8K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+8K201611Apex Knee SystemOmnilife Science20210—