510(k) Report

Devices descending from K040267

163 later devices reach Triathlon Cruciate Retaining (CR) Total Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+1K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+1K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+1K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+1K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd.20172—
+1K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+1K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+1K123692Pipeline Knee SystemPipeline Orthopedics20130—
+1K113060Unity Toatal Knee SystemCorin USA201283
+1K120313Neo CR Knee SystemPipeline Orthopedics20123—
+1K113122Pipeline CR Primary Knee SystemPipeline Orthopedics20121—
+1K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+1K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+1K071881Triathlon PKR SystemHowmedica Osteonics Corp.2007251
+1K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics200740—
+1K051380Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp.2005541
+1K042883Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertHowmedica Osteonics Corp.200448—
+2K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+2K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+2K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+2K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+2K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+2K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+2K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+2K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+2K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+2K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+2K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+2K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211
+2K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+2K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+2K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+2K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+2K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+2K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+2K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+2K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+2K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc.20190—
+2K183533Unity Total Knee SystemCorin U.S.A. Limited20191—
+2K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+2K173884Unity Total Knee SystemCorin U.S.A. Limited20182—
+2K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2017187
+2K170808Unity Total Knee SystemCorin U.S.A. Limited20170—
+2K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+2K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+2K131368Neo Knee SystemPipeline Orthopedics20131—
+2K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+2K122500Neo PS Knee SystemPipeline Orthopedics20131—
+2K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp.201333—
+2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+2K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+2K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+2K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+2K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+2K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+2K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+2K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+2K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+2K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+2K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+2K072575Triathlon Screw-Fixation Tibial BaseplateStryker Orthopaedics200829—
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+3K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+3K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+3K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+3K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+3K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+3K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+3K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+3K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+3K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+3K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+3K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+3K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+3K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+3K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—