510(k) Report

Devices descending from K040770

54 later devices reach Vanguard Patella Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+1K143543Prelude PF PatellaeBiomet, Inc.201501
+1K140902E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series…Biomet, Inc.20146—
+1K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Biomet Manufacturing Corp201311
+1K123692Pipeline Knee SystemPipeline Orthopedics20130—
+1K110362Vanguard Asymmetrical Patellar ComponentBiomet Manufacturing Corp20117—
+1K06134023 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc.200647—
+1K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210554Physica systemLima Corporate S.P.A.20212—
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+3K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+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
+3K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+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—
+4K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+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—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+4K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+4K143635KINETIS Total Knee SystemMako Surgical20150—
+4K140257Signature Planner, Signature GuidesMaterialise NV20140—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—