510(k) Report

Devices descending from K915132

315 later devices reach MCK Maximum Congruent Knee) Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+1K142933Biomet Tibial traysBiomet, Inc.201463
+1K102580Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp20119—
+1K102367Optigen Total Knee SystemU&I Corp.20100—
+1K093293Vanguard 360 Revision Knee SystemBiomet, Inc.2010215
+1K063732Microplasty Tibial TraysBiomet Manufacturing Corp20070—
+1K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619—
+1K042757Vanguard SSK Knee SystemBiomet, Inc.2005231
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460—
+1K033871IM Total FemurBiomet, Inc.20041—
+1K023546Maxim Accel Knee SystemBiomet, Inc.200330513
+1K984054Agc V2 Revision Knee SystemBiomet, Inc.19992—
+1K961021Kirschner Knee ModifiedBiomet, Inc.19977—
+1K964951Kinemax Plus Tibial SpacersHowmedica Corp.19970—
+2K210554Physica systemLima Corporate S.P.A.20212—
+2K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+2K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+2K143192Vanguard 360 Revision Knee SystemBiomet, Inc.20150—
+2K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+2K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+2K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Biomet Manufacturing Corp201311
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+2K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.201310—
+2K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp20127—
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+2K094013HLS Kneetec SystemTornier20111—
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K102125Patient-Specific Vanguard Femoral ComponetsBiomet, Inc.20116—
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+2K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+2K080204Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc.20086—
+2K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074—
+2K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+2K060525Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp2006163
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647—
+2K050222Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc.20052551
+2K033260AequosAap Implantate AG200419—
+2K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040—
+2K041046Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc.20042491
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+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—
+3K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+3K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.20240—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+3K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+3K1701493DMetal Tibial ConesMedacta International S.A.20170—
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+3K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K143543Prelude PF PatellaeBiomet, Inc.201501
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+3K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120—
+3K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+3K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+3K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+4K262057GMK ExtensionMedacta International SA20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+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—
+4K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+4K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+4K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—