510(k) Report

Devices descending from K031061

193 later devices reach Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+1K081023Evolis Total Knee SystemMedacta International S.A.2008781
+1K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc.20071024
+1K072160Nexgen Trabecular Metal Tibial TrayZimmer, Inc.20071081
+1K043101Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc.20055922
+1K041100Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200463
+1K042271Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular…Zimmer, Inc.2004162
+2K201084Physica systemLima Corporate S.P.A.20205—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+2K153657Vanguard XP Knee SystemBiomet, Inc.201611
+2K143635KINETIS Total Knee SystemMako Surgical20150—
+2K142069GMK ExtensionMedacta International20144—
+2K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+2K140257Signature Planner, Signature GuidesMaterialise NV20140—
+2K133630GMK Short StemMedacta International20131—
+2K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+2K131310GMK Full PE Tibial ComponentsMedacta International20132—
+2K122500Neo PS Knee SystemPipeline Orthopedics20131—
+2K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+2K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+2K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+2K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K121416GMK SphereMedacta International201220—
+2K120790GMK - Line ExtensionMedacta International201211—
+2K113571GMK Resufacing Patella Size 4Medacta International201223—
+2K111283GMK Revision Hybrid LinersMedacta International20110—
+2K090988GMK Total Knee SystemMedacta International S.A.2009521
+2K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+3K262057GMK ExtensionMedacta International SA20260—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+3K210062Mectaplug PE IIMedacta International S.A.20210—
+3K210554Physica systemLima Corporate S.P.A.20212—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+3K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+3K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+3K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+3K162035GMK SphereMedacta International S.A.201710—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+3K140826GMK Sphere ExtensionMedacta International201417—
+3K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+3K123721GMK Revision ExtensionMedacta International20133—
+3K122232GMK NarrowMedacta International20128—
+3K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103352Versafitcup CC TrioMedacta International20114—
+3K102437GMK Revision Knee SystemMedacta International S.A.201034—
+3K093806Myknee Cutting BlocksMedacta International S.A.201016—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+4K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+4K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—