510(k) Report

Devices descending from K032163

70 later devices reach Duracon Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd.20172—
+1K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics200740—
+1K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+1K051380Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp.2005541
+2K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+2K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+2K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+2K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+2K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+2K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc.20190—
+2K183533Unity Total Knee SystemCorin U.S.A. Limited20191—
+2K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+2K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2017187
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+2K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+2K131368Neo Knee SystemPipeline Orthopedics20131—
+2K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+2K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp.201333—
+2K072575Triathlon Screw-Fixation Tibial BaseplateStryker Orthopaedics200829—
+2K071881Triathlon PKR SystemHowmedica Osteonics Corp.2007251
+3K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+3K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+3K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+3K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+3K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+3K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+3K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+3K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+3K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+4K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+4K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+4K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+4K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211
+4K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+4K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+4K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K201611Apex Knee SystemOmnilife Science20210—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—