510(k) Report

Devices descending from K030612

141 later devices reach Genesis II Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+1K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.20195—
+1K140075U2 Femoral Component, CR, Porous CoatedUnited Orthopedic Corp.20143—
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K073325Legion Porous PrimarySmith & Nephew, Inc.200750—
+1K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.200575—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460—
+1K032683Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc.200319—
+1K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.2003766
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K221705U2 Total Knee System-PF+United Orthopedic Corporation20231—
+2K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd.20224—
+2K210554Physica systemLima Corporate S.P.A.20212—
+2K210566LEGION Porous CR Narrow Femoral ComponentsSmith & Nephew, Inc.20210—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+2K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174—
+2K150832U2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic Corporation20152—
+2K142933Biomet Tibial traysBiomet, Inc.201463
+2K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+2K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+2K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+2K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011403
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+2K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc.201012—
+2K091543Legion Porous Plus HA Primary Femoral ComponentsSmith & Nephew, Inc.20097—
+2K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+2K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.2007665
+2K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647—
+2K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.200514—
+2K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040—
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+3K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+3K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+3K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+3K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K211246LEGION CR Porous Plus HA Femoral ComponentsSmith & Nephew, Inc.20210—
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+3K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+3K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+3K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+3K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+3K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+3K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.201029—
+4K262057GMK ExtensionMedacta International SA20260—
+4K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+4K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—