510(k) Report

Devices descending from K041046

249 later devices reach Maxim Accel (Vanguard) PS+ Bearings through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+1K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+1K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+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—
+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—
+2K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+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—
+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—
+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—
+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—
+3K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+3K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+3K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+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—
+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—
+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
+3K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+4K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+4K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+4K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+4K172651FMP Extended LinersEncore Medical L.P.20173—
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+4K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161592Persona Partial Knee SystemBiomet, Inc.201652
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+4K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+4K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K140830Exprt Revision KneeEncore Medical L.P.201471
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—