510(k) Report

Devices descending from K023546

305 later devices reach Maxim Accel Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+1K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Biomet Manufacturing Corp201311
+1K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+1K102125Patient-Specific Vanguard Femoral ComponetsBiomet, Inc.20116—
+1K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+1K080204Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc.20086—
+1K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+1K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619—
+1K060525Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp2006163
+1K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647—
+1K050222Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc.20052551
+1K042757Vanguard SSK Knee SystemBiomet, Inc.2005231
+1K033260AequosAap Implantate AG200419—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460—
+1K041046Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc.20042491
+2K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+2K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+2K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+2K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+2K210554Physica systemLima Corporate S.P.A.20212—
+2K201084Physica systemLima Corporate S.P.A.20205—
+2K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+2K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+2K153657Vanguard XP Knee SystemBiomet, Inc.201611
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+2K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+2K143543Prelude PF PatellaeBiomet, Inc.201501
+2K142933Biomet Tibial traysBiomet, Inc.201463
+2K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+2K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K102580Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp20119—
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K093293Vanguard 360 Revision Knee SystemBiomet, Inc.2010215
+2K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+2K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+2K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+2K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074—
+2K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040—
+3K262057GMK ExtensionMedacta International SA20260—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+3K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+3K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+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—
+3K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+3K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+3K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+3K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+3K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.20240—
+3K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+3K1701493DMetal Tibial ConesMedacta International S.A.20170—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+3K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K143192Vanguard 360 Revision Knee SystemBiomet, Inc.20150—
+3K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+3K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+3K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+3K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+3K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+3K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+3K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.201310—
+3K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+3K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+3K121727Movation Knee SystemEncore Medical L.P.201214—
+3K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+3K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+3K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp20127—
+3K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+3K101336E1 Avantage HeadBiomet Manufacturing Corp2011241