510(k) Report

Devices descending from K072160

108 later devices reach Nexgen Trabecular Metal Tibial Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201084Physica systemLima Corporate S.P.A.20205—
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+1K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+1K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+1K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+2K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+2K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+2K213381Physica systemLima Corporate S.P.A.202101
+2K211938Physica LMC Knee SystemLimacorporate20210—
+2K210554Physica systemLima Corporate S.P.A.20212—
+2K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+2K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+2K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+2K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+2K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+2K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+2K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+2K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+2K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+2K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+2K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+3K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+3K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+3K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+3K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+3K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+3K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+3K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+3K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+3K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+3K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+3K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+3K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+3K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+3K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+3K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+3K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+3K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+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—
+3K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+3K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+3K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+3K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211
+3K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+3K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+3K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+3K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+3K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+3K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+4K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+4K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+4K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+4K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+4K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+4K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+4K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+4K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—